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Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC)

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ClinicalTrials.gov Identifier: NCT01550367
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : September 25, 2019
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
Prometheus Laboratories
Information provided by (Responsible Party):
Leonard Appleman, University of Pittsburgh

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Renal Cell Carcinoma
Interventions Drug: Hydroxychloroquine
Drug: IL-2
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description

One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Period Title: Overall Study
Started 30
1200 mg/d HCQ 13
600 mg/d HCQ 17
Completed 30
Not Completed 0
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description

One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine. Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
1200 mg/d HCQ Number Analyzed 13 participants
58.2
(55.0 to 61.3)
600 mg/d HCQ Number Analyzed 17 participants
56.5
(52.0 to 60.9)
[1]
Measure Analysis Population Description: Measure Analysis Population Description: Rows represent different dosage levels of HCQ.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
1200 mg/d HCQ Number Analyzed 13 participants
Female
4
  30.8%
Male
9
  69.2%
600 mg/d HCQ Number Analyzed 17 participants
Female
4
  23.5%
Male
13
  76.5%
[1]
Measure Analysis Population Description: Rows represent different dosage levels of HCQ.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
All Patients Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
30
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Karnofsky Performance Status (KPS)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
KPS Score - 1200 mg/d HCQ Number Analyzed 13 participants
KPS Score of 80
11
  84.6%
KPS Score of 90
1
   7.7%
KPS Score of 100
1
   7.7%
KPS Score - 600 mg/d HCQ Number Analyzed 17 participants
KPS Score of 80
13
  76.5%
KPS Score of 90
0
   0.0%
KPS Score of 100
4
  23.5%
[1]
Measure Description: The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. Karnofsky Performance Status may be used to determine a patient's prognosis, to measure changes in a patient's ability to function, or to decide if a patient could be included in a clinical trial.
[2]
Measure Analysis Population Description: Indicating Karnofsky Status by HCQ dosage group
1.Primary Outcome
Title Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at Either 1,200 mg/d or 600 mg/d) (All Patients)
Hide Description Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ at either 1,200 mg/d or 600 mg/d) who were evaluable for clinical response. Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dosing was reduced to 600 mg/d.
Arm/Group Title Hydroxychloroquine + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.

Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
Progressed Disease - All Patients
9
  31.0%
Stable Disease - All Patients
14
  48.3%
Partial Response - All Patients
3
  10.3%
Complete Response - All Patients
3
  10.3%
2.Primary Outcome
Title Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 1,200 mg/d
Hide Description Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ) 1,200 mg/d who were evaluable for clinical response.
Arm/Group Title Hydroxychloroquine + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d) will be initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
Progressed Disease
5
  41.7%
Stable Disease
6
  50.0%
Partial Response
1
   8.3%
Complete Response
0
   0.0%
3.Primary Outcome
Title Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 600 mg/d
Hide Description Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ) 600 mg/d who were evaluable for clinical response.
Arm/Group Title Hydroxychloroquine + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
Progressed Disease
4
  23.5%
Stable Disease
8
  47.1%
Partial Response
2
  11.8%
Complete Response
3
  17.6%
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description Time from date of first protocol treatment until the date of death, or censored at date of last contact.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ).
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d.

Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(29.6 to NA)
[1]
Median and upper limit estimated overall survival in this trial is not yet achieved due to insufficient number of events (deaths).
5.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Time from the date of first protocol treatment until the date disease progression criteria are met (in responding patients progression criteria uses the reference of the smallest measurements recorded since the treatment started) or is censored at date of last disease assessment for those who have not progressed. Per RECIST 1.1, Progressive Disease (PD) is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ) at either 600 mg/d or 1,200 mg/d.
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d.

Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
5.5
(3.0 to 14.0)
6.Secondary Outcome
Title Number of Doses of IL-2 + HCQ
Hide Description Number of doses of IL-2 administered during the first course of therapy.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received at least one dose of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ).
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d.

Overall Number of Participants Analyzed 30
Mean (95% Confidence Interval)
Unit of Measure: doses
1200 mg/d HCQ Number Analyzed 13 participants
12.8
(9.8 to 15.7)
600 mg/d HCQ Number Analyzed 17 participants
13.2
(11.0 to 15.4)
7.Secondary Outcome
Title Frequency of Grade III and Grade IV Toxicities
Hide Description Number of specified categories of grade III and IV or unexpected or rare toxicities occurring during the first course (up until the end of cycle 1) of IL-2 treatment.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received at least one dose (cycle) of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ) and experienced specified categories of toxicities.
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d.

Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: events
Hypotension 5
Gastrointestinal 1
Hematologic 1
Pulmonary 1
Renal/electrolytes 4
Psychiatric 3
8.Secondary Outcome
Title Worst Grade of Adverse Event Experienced
Hide Description Number of participants who experienced Grade 2-5 adverse events.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received at least one dose of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ).
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d.

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
1200 mg/d HCQ Number Analyzed 13 participants
Grade 2 adverse event
1
   7.7%
Grade 3 adverse event
4
  30.8%
Grade 4 adverse event
7
  53.8%
Grade 5 adverse event
1
   7.7%
600 mg/d HCQ Number Analyzed 17 participants
Grade 2 adverse event
0
   0.0%
Grade 3 adverse event
4
  23.5%
Grade 4 adverse event
13
  76.5%
Grade 5 adverse event
0
   0.0%
9.Secondary Outcome
Title Worst Grade of Adverse Event At Least Possibly Related to Treatment Experienced
Hide Description Number of participants who experienced Grade 2-5 adverse events that were at least possibly related to study treatment.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received at least one dose of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ).
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
1200 mg/d HCQ Number Analyzed 13 participants
Grade 2 adverse event
1
   7.7%
Grade 3 adverse event
5
  38.5%
Grade 4 adverse event
7
  53.8%
600 mg/d HCQ Number Analyzed 17 participants
Grade 2 adverse event
0
   0.0%
Grade 3 adverse event
4
  23.5%
Grade 4 adverse event
13
  76.5%
10.Secondary Outcome
Title Worst Grade of Adverse Event At Least Probably Related to Treatment Experienced
Hide Description Number of participants who experienced Grade 2-5 adverse events that were at least probably related to study treatment.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received at least one dose of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ).
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
1200 mg/d HCQ Number Analyzed 13 participants
Grade 2 adverse event
1
   7.7%
Grade 3 adverse event
5
  38.5%
Grade 4 adverse event
7
  53.8%
600 mg/d HCQ Number Analyzed 17 participants
Grade 2 adverse event
2
  11.8%
Grade 3 adverse event
4
  23.5%
Grade 4 adverse event
11
  64.7%
11.Secondary Outcome
Title Serum Lactate Dehydrogenase
Hide Description Number of participants with either high serum lactate dehydrogenase (> 1.5 times upper limit of normal) or normal lactate dehydrogenase.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received study treatment for whom LDH was able to be measured from clinical samples and determined to be either normal or high.
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d.

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Normal LDH Number Analyzed 28 participants
1200 mg/d HCQ
11
  39.3%
600 mg/d HCQ
17
  60.7%
High LDH Number Analyzed 2 participants
1200 mg/d HCQ
2
 100.0%
600 mg/d HCQ
0
   0.0%
12.Secondary Outcome
Title Hemoglobin Levels
Hide Description Low hemoglobin levels (less than the lower limit of normal (13.2 g/dL)) are considered to be unfavorable.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patient that received study treatment for whom hemoglobin levels were able to be measured from clinical samples and determined to be either normal or low.
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Low hemoglobin level Number Analyzed 9 participants
1200 mg/d HCQ
6
  66.7%
600 mg/d HCQ
3
  33.3%
Normal hemoglobin level Number Analyzed 21 participants
1200 mg/d HCQ
7
  33.3%
600 mg/d HCQ
14
  66.7%
13.Secondary Outcome
Title Serum Calcium Levels (Corrected)
Hide Description Number of patients with either normal or high serum calcium levels. High serum calcium levels are considered to be clinically unfavorable.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received study treatment for whom serum calcium levels were able to be measured from clinical samples and determined to be either normal or high.
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Normal Calcium Number Analyzed 27 participants
1200 mg/d HCQ
13
  48.1%
600 mg/d HCQ
14
  51.9%
High Calcium Number Analyzed 3 participants
1200 mg/d HCQ
0
   0.0%
600 mg/d HCQ
3
 100.0%
14.Secondary Outcome
Title Prior Nephrectomy
Hide Description Number of patients with history of a prior nephrectomy (surgical removal of a kidney) or no history of a prior nephrectomy.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received study treatment, with or without a history of nephrectomy (surgical removal of a kidney).
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
No Prior Nephrectomy Number Analyzed 3 participants
600 mg/d HCQ
3
 100.0%
1200 mg/d HCQ
0
   0.0%
Prior Nephrectomy Number Analyzed 27 participants
600 mg/d HCQ
14
  51.9%
1200 mg/d HCQ
13
  48.1%
15.Secondary Outcome
Title Number of Participants With Low Karnofsky Performance Status
Hide Description Karnofsky performance status is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. Karnofsky Performance Status may be used to determine a patient's prognosis, to measure changes in a patient's ability to function, or to decide if a patient should be included in the trial. A low Karnofsky performance status (<80%) is considered to be unfavorable.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patient that received study treatment for whom Karnofsky performance status was able to be assessed.
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
1200 mg/d HCQ Number Analyzed 13 participants
0
   0.0%
600 mg/d HCQ Number Analyzed 17 participants
0
   0.0%
16.Secondary Outcome
Title Natural Killer (NK) Cells
Hide Description Percentage of Natural Killer (NK) cells per ml of blood. NK cells are lymphocytes with the ability to kill tumor cells without deliberate immunization or activation.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received study treatment for whom Natural Killer (NK) cells were able to be measured.
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Overall Number of Participants Analyzed 30
Mean (Full Range)
Unit of Measure: percentage of cells
38.4
(3.7 to 67.3)
17.Secondary Outcome
Title Myeloid Derived Suppressor Cell (MDSC)
Hide Description Percentage of Myeloid Derived Suppressor Cell per ml of blood. MDSC immune cells originate from bone marrow stem cells and strongly expand in cancer.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received study treatment for whom MDSC were able to be measured.
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Overall Number of Participants Analyzed 30
Mean (Full Range)
Unit of Measure: percentage of cells/mL
11.3
(4.4 to 23.6)
18.Secondary Outcome
Title Regulatory T Cells (Treg)
Hide Description Percentage of Regulatory T cells per ml of blood. High levels of Tregs in the tumor microenvironment are associated with poor prognosis in many cancers by suppressing the body's anti-tumor immune response.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received study treatment for whom Regulatory T cells (Treg) were able to be measured.
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Overall Number of Participants Analyzed 30
Mean (Full Range)
Unit of Measure: percentage of cells/mL
10.5
(1.7 to 20.8)
19.Secondary Outcome
Title Plasmacytoid Dendritic Cells (pDC)
Hide Description Percentage of Plasmacytoid dendritic cells per ml of blood. In cancer, pDC are malignant immune cells that demonstrate an impaired response that can contribute to the establishment of an immunosuppressive tumor microenvironment.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received study treatment for whom Plasmacytoid dendritic Cells (pDC) were able to be measured.
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Overall Number of Participants Analyzed 30
Mean (Full Range)
Unit of Measure: percentage of cells/mL
0.3
(0.1 to 0.8)
20.Secondary Outcome
Title T-cell Lymphocytes
Hide Description Percentage of T-cell lymphocytes in blood as cells per ml. T-cells are a subtype of white blood cells which play a key role in the immune system and fighting cancer.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received study treatment for whom T-Cells were able to be measured.
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Overall Number of Participants Analyzed 30
Mean (Full Range)
Unit of Measure: percentage of cells/mL
63.9
(17.7 to 80.5)
21.Secondary Outcome
Title Conventional Dendritic Cells (cDC)
Hide Description Percentage of Conventional Dendritic Cells (cDC) per ml of blood. cDC reside in tissues and once activated, migrate to draining lymph nodes to promote adaptive immune responses.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received study treatment for whom Conventional Dendritic Cells (cDC) were able to be measured.
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
Hide Arm/Group Description:

One course of treatment (84 days) consisted of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

Overall Number of Participants Analyzed 30
Mean (Full Range)
Unit of Measure: percentage of cells/mL
0.6
(0 to 1.5)
Time Frame Up to 3 years for cohort.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hydroxychloroquine (HCQ) (1,200 mg/d ) + IL-2 Hydroxychloroquine (HCQ) (600 mg/d) + IL-2
Hide Arm/Group Description

One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d (initial (13) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.

Hydroxychloroquine: Continuous oral administration at 600 mg/d (17 patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.

IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course

Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).

All-Cause Mortality
Hydroxychloroquine (HCQ) (1,200 mg/d ) + IL-2 Hydroxychloroquine (HCQ) (600 mg/d) + IL-2
Affected / at Risk (%) Affected / at Risk (%)
Total   9/13 (69.23%)      2/17 (11.76%)    
Hide Serious Adverse Events
Hydroxychloroquine (HCQ) (1,200 mg/d ) + IL-2 Hydroxychloroquine (HCQ) (600 mg/d) + IL-2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/13 (92.31%)      17/17 (100.00%)    
Blood and lymphatic system disorders     
Anemia   1/13 (7.69%)  1 2/17 (11.76%)  4
Cardiac disorders     
Atrial fibrillation   1/13 (7.69%)  1 0/17 (0.00%)  0
Cardiac disorders - Other, specify   2/13 (15.38%)  2 0/17 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain   1/13 (7.69%)  1 0/17 (0.00%)  0
Diarrhea   0/13 (0.00%)  0 1/17 (5.88%)  1
Mucositis oral   1/13 (7.69%)  2 1/17 (5.88%)  1
Nausea   1/13 (7.69%)  1 1/17 (5.88%)  1
General disorders     
Death NOS   1/13 (7.69%)  1 0/17 (0.00%)  0
Hepatobiliary disorders     
Bile duct stenosis   1/13 (7.69%)  1 0/17 (0.00%)  0
Investigations     
Alanine aminotransferase increased   1/13 (7.69%)  1 0/17 (0.00%)  0
Alkaline phosphatase increased   1/13 (7.69%)  1 0/17 (0.00%)  0
Blood bilirubin increased   2/13 (15.38%)  2 1/17 (5.88%)  1
Investigations - Other, specify   0/13 (0.00%)  0 1/17 (5.88%)  2
Lipase increased   2/13 (15.38%)  8 1/17 (5.88%)  1
Lymphocyte count decreased   6/13 (46.15%)  37 13/17 (76.47%)  66
Neutrophil count decreased   0/13 (0.00%)  0 2/17 (11.76%)  2
Platelet count decreased   3/13 (23.08%)  4 1/17 (5.88%)  1
Serum amylase increased   3/13 (23.08%)  4 0/17 (0.00%)  0
Urine output decreased   1/13 (7.69%)  1 0/17 (0.00%)  0
White blood cell decreased   1/13 (7.69%)  1 0/17 (0.00%)  0
Metabolism and nutrition disorders     
Hypercalcemia   0/13 (0.00%)  0 1/17 (5.88%)  1
Hyperkalemia   0/13 (0.00%)  0 1/17 (5.88%)  1
Hypoalbuminemia   5/13 (38.46%)  8 3/17 (17.65%)  6
Hypocalcemia   2/13 (15.38%)  2 0/17 (0.00%)  0
Hypokalemia   1/13 (7.69%)  1 0/17 (0.00%)  0
Hyponatremia   2/13 (15.38%)  2 2/17 (11.76%)  3
Hypophosphatemia   6/13 (46.15%)  19 15/17 (88.24%)  41
Nervous system disorders     
Akathisia   1/13 (7.69%)  1 0/17 (0.00%)  0
Psychiatric disorders     
Agitation   1/13 (7.69%)  1 0/17 (0.00%)  0
Anxiety   1/13 (7.69%)  2 2/17 (11.76%)  2
Confusion   1/13 (7.69%)  1 0/17 (0.00%)  0
Delirium   0/13 (0.00%)  0 1/17 (5.88%)  1
Renal and urinary disorders     
Renal and urinary disorders - Other, specify   2/13 (15.38%)  2 0/17 (0.00%)  0
Urinary retention   5/13 (38.46%)  10 3/17 (17.65%)  6
Respiratory, thoracic and mediastinal disorders     
Apnea   1/13 (7.69%)  1 0/17 (0.00%)  0
Dyspnea   2/13 (15.38%)  2 1/17 (5.88%)  1
Hypoxia   1/13 (7.69%)  1 0/17 (0.00%)  0
Pulmonary edema   1/13 (7.69%)  1 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify   1/13 (7.69%)  1 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus   0/13 (0.00%)  0 1/17 (5.88%)  1
Vascular disorders     
Hypertension   1/13 (7.69%)  1 1/17 (5.88%)  1
Hypotension   6/13 (46.15%)  9 2/17 (11.76%)  2
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hydroxychloroquine (HCQ) (1,200 mg/d ) + IL-2 Hydroxychloroquine (HCQ) (600 mg/d) + IL-2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/13 (100.00%)      17/17 (100.00%)    
Blood and lymphatic system disorders     
Anemia   8/13 (61.54%)  41 13/17 (76.47%)  50
Blood and lymphatic system disorders - Other, specify   1/13 (7.69%)  1 0/17 (0.00%)  0
Cardiac disorders     
Atrial fibrillation   1/13 (7.69%)  1 0/17 (0.00%)  0
Cardiac disorders - Other, specify   4/13 (30.77%)  6 5/17 (29.41%)  10
Heart failure   0/13 (0.00%)  0 1/17 (5.88%)  1
Myocarditis   1/13 (7.69%)  1 0/17 (0.00%)  0
Sinus bradycardia   0/13 (0.00%)  0 1/17 (5.88%)  1
Sinus tachycardia   7/13 (53.85%)  14 6/17 (35.29%)  8
Endocrine disorders     
Hypothyroidism   1/13 (7.69%)  1 0/17 (0.00%)  0
Eye disorders     
Blurred vision   0/13 (0.00%)  0 1/17 (5.88%)  1
Eye disorders - Other, specify   1/13 (7.69%)  1 0/17 (0.00%)  0
Flashing lights   0/13 (0.00%)  0 1/17 (5.88%)  1
Photophobia   1/13 (7.69%)  1 1/17 (5.88%)  1
Gastrointestinal disorders     
Abdominal pain   3/13 (23.08%)  6 3/17 (17.65%)  3
Ascites   1/13 (7.69%)  1 0/17 (0.00%)  0
Constipation   4/13 (30.77%)  4 1/17 (5.88%)  1
Diarrhea   11/13 (84.62%)  27 13/17 (76.47%)  28
Dry mouth   2/13 (15.38%)  3 1/17 (5.88%)  1
Dyspepsia   3/13 (23.08%)  5 1/17 (5.88%)  1
Gastroesophageal reflux disease   0/13 (0.00%)  0 1/17 (5.88%)  1
Gastrointestinal disorders - Other, specify   2/13 (15.38%)  2 2/17 (11.76%)  3
Mucositis oral   6/13 (46.15%)  10 7/17 (41.18%)  11
Nausea   12/13 (92.31%)  30 14/17 (82.35%)  40
Oral pain   1/13 (7.69%)  2 0/17 (0.00%)  0
Pancreatitis   3/13 (23.08%)  4 0/17 (0.00%)  0
Vomiting   9/13 (69.23%)  21 11/17 (64.71%)  25
General disorders     
Chills   9/13 (69.23%)  16 8/17 (47.06%)  17
Death NOS   1/13 (7.69%)  1 0/17 (0.00%)  0
Edema face   0/13 (0.00%)  0 2/17 (11.76%)  2
Edema limbs   9/13 (69.23%)  19 10/17 (58.82%)  18
Fatigue   9/13 (69.23%)  28 12/17 (70.59%)  34
Fever   3/13 (23.08%)  4 7/17 (41.18%)  23
Gait disturbance   1/13 (7.69%)  1 0/17 (0.00%)  0
General disorders and administration site conditions - Other, specify   8/13 (61.54%)  18 9/17 (52.94%)  18
Localized edema   0/13 (0.00%)  0 1/17 (5.88%)  2
Malaise   3/13 (23.08%)  3 0/17 (0.00%)  0
Non-cardiac chest pain   1/13 (7.69%)  1 1/17 (5.88%)  1
Pain   1/13 (7.69%)  1 5/17 (29.41%)  6
Hepatobiliary disorders     
Bile duct stenosis   1/13 (7.69%)  1 0/17 (0.00%)  0
Immune system disorders     
Allergic reaction   0/13 (0.00%)  0 3/17 (17.65%)  3
Infections and infestations     
Mucosal infection   0/13 (0.00%)  0 1/17 (5.88%)  1
Sinusitis   0/13 (0.00%)  0 1/17 (5.88%)  1
Skin infection   1/13 (7.69%)  1 0/17 (0.00%)  0
Soft tissue infection   0/13 (0.00%)  0 1/17 (5.88%)  1
Tooth infection   0/13 (0.00%)  0 1/17 (5.88%)  1
Upper respiratory infection   1/13 (7.69%)  1 1/17 (5.88%)  3
Urinary tract infection   0/13 (0.00%)  0 2/17 (11.76%)  2
Injury, poisoning and procedural complications     
Fall   0/13 (0.00%)  0 1/17 (5.88%)  1
Investigations     
Activated partial thromboplastin time prolonged   0/13 (0.00%)  0 1/17 (5.88%)  1
Alanine aminotransferase increased   6/13 (46.15%)  9 8/17 (47.06%)  12
Alkaline phosphatase increased   8/13 (61.54%)  26 6/17 (35.29%)  16
Aspartate aminotransferase increased   7/13 (53.85%)  10 8/17 (47.06%)  9
Blood bilirubin increased   8/13 (61.54%)  23 9/17 (52.94%)  22
CPK increased   3/13 (23.08%)  5 1/17 (5.88%)  1
Cardiac troponin I increased   1/13 (7.69%)  1 0/17 (0.00%)  0
Creatinine increased   7/13 (53.85%)  39 12/17 (70.59%)  64
INR increased   0/13 (0.00%)  0 4/17 (23.53%)  5
Investigations - Other, specify   5/13 (38.46%)  9 11/17 (64.71%)  15
Lipase increased   4/13 (30.77%)  21 6/17 (35.29%)  12
Lymphocyte count decreased   6/13 (46.15%)  43 13/17 (76.47%)  76
Neutrophil count decreased   2/13 (15.38%)  3 4/17 (23.53%)  6
Platelet count decreased   8/13 (61.54%)  25 12/17 (70.59%)  45
Serum amylase increased   4/13 (30.77%)  18 2/17 (11.76%)  7
Urine output decreased   1/13 (7.69%)  1 1/17 (5.88%)  1
Weight gain   5/13 (38.46%)  6 8/17 (47.06%)  12
Weight loss   2/13 (15.38%)  3 3/17 (17.65%)  4
White blood cell decreased   5/13 (38.46%)  8 6/17 (35.29%)  13
Metabolism and nutrition disorders     
Acidosis   1/13 (7.69%)  1 0/17 (0.00%)  0
Anorexia   6/13 (46.15%)  11 6/17 (35.29%)  13
Hypercalcemia   1/13 (7.69%)  2 2/17 (11.76%)  5
Hyperglycemia   0/13 (0.00%)  0 4/17 (23.53%)  4
Hyperkalemia   6/13 (46.15%)  13 4/17 (23.53%)  10
Hypermagnesemia   1/13 (7.69%)  1 3/17 (17.65%)  6
Hypertriglyceridemia   1/13 (7.69%)  1 0/17 (0.00%)  0
Hyperuricemia   0/13 (0.00%)  0 1/17 (5.88%)  1
Hypoalbuminemia   8/13 (61.54%)  61 14/17 (82.35%)  77
Hypocalcemia   7/13 (53.85%)  14 12/17 (70.59%)  30
Hypoglycemia   2/13 (15.38%)  2 1/17 (5.88%)  1
Hypokalemia   3/13 (23.08%)  3 6/17 (35.29%)  9
Hypomagnesemia   11/13 (84.62%)  28 16/17 (94.12%)  48
Hyponatremia   9/13 (69.23%)  28 13/17 (76.47%)  36
Hypophosphatemia   10/13 (76.92%)  37 16/17 (94.12%)  75
Metabolism and nutrition disorders - Other, specify   2/13 (15.38%)  4 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia   0/13 (0.00%)  0 1/17 (5.88%)  1
Arthritis   1/13 (7.69%)  2 2/17 (11.76%)  2
Back pain   2/13 (15.38%)  2 2/17 (11.76%)  2
Chest wall pain   1/13 (7.69%)  1 0/17 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify   2/13 (15.38%)  3 2/17 (11.76%)  4
Myalgia   0/13 (0.00%)  0 2/17 (11.76%)  2
Neck pain   0/13 (0.00%)  0 1/17 (5.88%)  1
Pain in extremity   0/13 (0.00%)  0 3/17 (17.65%)  3
Nervous system disorders     
Akathisia   1/13 (7.69%)  2 2/17 (11.76%)  2
Dizziness   1/13 (7.69%)  1 3/17 (17.65%)  3
Dysgeusia   3/13 (23.08%)  4 3/17 (17.65%)  6
Headache   4/13 (30.77%)  4 4/17 (23.53%)  5
Nervous system disorders - Other, specify   3/13 (23.08%)  3 3/17 (17.65%)  6
Paresthesia   1/13 (7.69%)  1 0/17 (0.00%)  0
Peripheral sensory neuropathy   1/13 (7.69%)  1 1/17 (5.88%)  1
Tremor   1/13 (7.69%)  1 0/17 (0.00%)  0
Psychiatric disorders     
Agitation   2/13 (15.38%)  2 1/17 (5.88%)  1
Anxiety   5/13 (38.46%)  14 11/17 (64.71%)  17
Confusion   3/13 (23.08%)  4 2/17 (11.76%)  2
Delirium   0/13 (0.00%)  0 2/17 (11.76%)  2
Hallucinations   1/13 (7.69%)  1 4/17 (23.53%)  4
Insomnia   5/13 (38.46%)  6 5/17 (29.41%)  5
Psychiatric disorders - Other, specify   2/13 (15.38%)  2 1/17 (5.88%)  1
Restlessness   0/13 (0.00%)  0 1/17 (5.88%)  1
Renal and urinary disorders     
Acute kidney injury   3/13 (23.08%)  3 0/17 (0.00%)  0
Hematuria   2/13 (15.38%)  2 0/17 (0.00%)  0
Proteinuria   6/13 (46.15%)  8 4/17 (23.53%)  11
Renal and urinary disorders - Other, specify   2/13 (15.38%)  2 4/17 (23.53%)  5
Urinary retention   6/13 (46.15%)  12 5/17 (29.41%)  10
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis   3/13 (23.08%)  4 1/17 (5.88%)  1
Apnea   1/13 (7.69%)  1 0/17 (0.00%)  0
Cough   2/13 (15.38%)  5 7/17 (41.18%)  7
Dyspnea   10/13 (76.92%)  15 7/17 (41.18%)  8
Epistaxis   0/13 (0.00%)  0 1/17 (5.88%)  1
Hiccups   1/13 (7.69%)  1 0/17 (0.00%)  0
Hoarseness   1/13 (7.69%)  1 0/17 (0.00%)  0
Hypoxia   3/13 (23.08%)  3 0/17 (0.00%)  0
Pleural effusion   0/13 (0.00%)  0 1/17 (5.88%)  1
Pulmonary edema   1/13 (7.69%)  1 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify   2/13 (15.38%)  3 5/17 (29.41%)  8
Wheezing   3/13 (23.08%)  3 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia   0/13 (0.00%)  0 1/17 (5.88%)  1
Dry skin   7/13 (53.85%)  10 9/17 (52.94%)  20
Erythema multiforme   2/13 (15.38%)  2 0/17 (0.00%)  0
Pruritus   11/13 (84.62%)  22 10/17 (58.82%)  21
Rash acneiform   2/13 (15.38%)  2 1/17 (5.88%)  1
Rash maculo-papular   0/13 (0.00%)  0 3/17 (17.65%)  5
Skin and subcutaneous tissue disorders - Other, specify   3/13 (23.08%)  3 4/17 (23.53%)  4
Skin hyperpigmentation   0/13 (0.00%)  0 1/17 (5.88%)  1
Urticaria   0/13 (0.00%)  0 1/17 (5.88%)  1
Vascular disorders     
Capillary leak syndrome   0/13 (0.00%)  0 4/17 (23.53%)  4
Flushing   8/13 (61.54%)  15 8/17 (47.06%)  19
Hot flashes   0/13 (0.00%)  0 1/17 (5.88%)  1
Hypertension   1/13 (7.69%)  1 4/17 (23.53%)  6
Hypotension   11/13 (84.62%)  26 12/17 (70.59%)  29
Superficial thrombophlebitis   0/13 (0.00%)  0 1/17 (5.88%)  1
Thromboembolic event   0/13 (0.00%)  0 2/17 (11.76%)  2
Vascular disorders - Other, specify   1/13 (7.69%)  1 1/17 (5.88%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Barbara Stadterman, MPH, MCCR, Regulatory Supervisor, CRS
Organization: UPMC Hillman Cancer Center
Phone: 412-647-5554
EMail: stadtermanbm@upmc.edu
Layout table for additonal information
Responsible Party: Leonard Appleman, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01550367    
Other Study ID Numbers: UPCI 11-080
First Submitted: February 29, 2012
First Posted: March 12, 2012
Results First Submitted: July 17, 2019
Results First Posted: September 25, 2019
Last Update Posted: January 2, 2020