We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma. (SBRT/IL-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01416831
Recruitment Status : Active, not recruiting
First Posted : August 15, 2011
Results First Posted : November 15, 2022
Last Update Posted : March 27, 2023
Sponsor:
Collaborator:
Prometheus Laboratories
Information provided by (Responsible Party):
Providence Health & Services

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Melanoma
Interventions Other: Radiation therapy and high-dose IL-2
Drug: High-dose IL-2
Enrollment 44
Recruitment Details A total of 63 potential patients were screened for eligibility at Providence Cancer Institute Franz Clinic and Compass Oncology East Clinic from 2011 to 2017.
Pre-assignment Details Of the 50 patients who signed consent, six were excluded (3 due to rapid melanoma progression during screening, 2 due to cardiac ischemia on exercise tolerance testing, and 1 due to insurance issues). Of the 44 enrolled patients, 20 were assigned to Arm A, and 7 of those patients chose to participate in the optional crossover portion of the study.
Arm/Group Title Arm A: IL-2 Monotherapy Arm B: SBRT + IL-2
Hide Arm/Group Description

Patients receive standard high-dose IL-2 therapy, with an opportunity to crossover to the experimental arm if there is disease progression noted after two cycles of high-dose IL-2. Crossover patients will be included in Arm A.

High-dose IL-2: IL-2 will be given on a Monday at a dose of 600,000 IU per kilogram IV every 8 hours for up to 14 doses each cycle. The second cycle is planned 16 days after cycle 1 but may be delayed up to one week to allow toxicity to resolve. The maximum number of doses that can be given during two cycles will be 28 doses. Patients who respond after two cycles can receive 4 more cycles of IL-2. Patients with disease progression after 2 cycles may elect to receive radiation before a 3rd cycle of IL-2. If patients crossover, IL-2 will be given on the Monday following the last dose of radiation, at a dose of 600,000 IU per kilogram IV every 8 hours for a maximum of 14 doses each cycle. Another cycle is planned 16 days after cycle 3 but may be delayed up to one week to allow toxicity to resolve.

Patients 1-20 who are assigned to receive radiation therapy will receive a single dose of radiation before IL-2; patients 21-44 assigned to receive radiation will receive two doses of radiation before receiving high-dose IL-2.

Radiation therapy and high-dose IL-2: Patients 1 - 20 will receive a single fraction of radiation. Patients 21 through the completion of the study will receive two fractions. The dose for all patients will be 20 Gy per fraction to the prescription line at the edge of the planning treatment volume (PTV) with the last dose delivered on a Friday before IL-2 administration. For patients receiving two radiation doses, the doses can be administered on the Wednesday and Friday before IL-2 starts. Patients who are assigned to IL-2 monotherapy and have progressive disease after two IL-2 cycles are then eligible to receive SBRT before cycle 3 of IL-2 commences, single fraction for patients 1-20 and two fractions for patients 21- end of study.
Period Title: Cycles 1 & 2 (Weeks 1-14)
Started 20 24
Completed 19 22
Not Completed 1 2
Reason Not Completed
Death             1             2
Period Title: SBRT Crossover Period
Started [1] 7 0
Completed 7 0
Not Completed 0 0
[1]
Of the 8 patients enrolled into Arm A whose melanoma progressed after the first imaging, 7 agreed to participate in the crossover portion of the study after completion of Cycle 2.
Arm/Group Title Arm A: IL-2 Monotherapy Arm B: SBRT + IL-2 Total
Hide Arm/Group Description

Patients receive standard high-dose IL-2 therapy, with an opportunity to crossover to the experimental arm if there is disease progression noted after two cycles of high-dose IL-2. Crossover patients will be included in Arm A.

High-dose IL-2: IL-2 will be given on a Monday at a dose of 600,000 IU per kilogram IV every 8 hours for up to 14 doses each cycle. The second cycle is planned 16 days after cycle 1 but may be delayed up to one week to allow toxicity to resolve. The maximum number of doses that can be given during two cycles will be 28 doses. Patients who respond after two cycles can receive 4 more cycles of IL-2. Patients with disease progression after 2 cycles may elect to receive radiation before a 3rd cycle of IL-2. If patients crossover, IL-2 will be given on the Monday following the last dose of radiation, at a dose of 600,000 IU per kilogram IV every 8 hours for a maximum of 14 doses each cycle. Another cycle is planned 16 days after cycle 3 but may be delayed up to one week to allow toxicity to resolve.

Patients 1-20 who are assigned to receive radiation therapy will receive a single dose of radiation before IL-2; patients 21-44 assigned to receive radiation will receive two doses of radiation before receiving high-dose IL-2.

Radiation therapy and high-dose IL-2: Patients 1 - 20 will receive a single fraction of radiation. Patients 21 through the completion of the study will receive two fractions. The dose for all patients will be 20 Gy per fraction to the prescription line at the edge of the planning treatment volume (PTV) with the last dose delivered on a Friday before IL-2 administration. For patients receiving two radiation doses, the doses can be administered on the Wednesday and Friday before IL-2 starts. Patients who are assigned to IL-2 monotherapy and have progressive disease after two IL-2 cycles are then eligible to receive SBRT before cycle 3 of IL-2 commences, single fraction for patients 1-20 and two fractions for patients 21- end of study.

 Total of all reporting groups
Overall Number of Baseline Participants 20 24 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 24 participants 44 participants
57.5
(30 to 82)
53
(21 to 75)
57
(21 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 24 participants 44 participants
Female
4
  20.0%
6
  25.0%
10
  22.7%
Male
16
  80.0%
18
  75.0%
34
  77.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 24 participants 44 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
20
 100.0%
24
 100.0%
44
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 24 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
20
 100.0%
24
 100.0%
44
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 24 participants 44 participants
20 24 44
BRAF Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 24 participants 44 participants
Mutated
11
  55.0%
7
  29.2%
18
  40.9%
Wild Type
5
  25.0%
14
  58.3%
19
  43.2%
Unknown
4
  20.0%
3
  12.5%
7
  15.9%
1.Primary Outcome
Title Best Overall Tumor Response of High Dose IL-2 vs. SBRT + High Dose IL-2
Hide Description

Determine the best overall tumor response rate of high dose IL-2 versus SBRT + high-dose IL-2 using RECIST v1.1 assessed by CT/MRI, criteria applied to all target and non-target lesions with the exclusion of sites treated with SBRT. For patients who have SBRT after progression on IL-2 monotherapy, the response rate will be recorded, but not counted as a response for the primary objective.

Overall response rate (ORR) includes all measurable and non-measurable target lesions except the lesions treated by SBRT, which were assessed separately. Both CT and positron emission tomography imaging were employed to assess response.

Complete Response: disappearance of all target/non-target lesions and no abnormalities on PET; Partial Response: ≥30% decrease in sum of longest diameter (LD) of target lesions; Progressive Disease: ≥20% increase in sum of LD recorded since tx start or appearance of ≥1 new lesions; Stable Disease: Neither qualifying for PR nor PD since tx started.
Time Frame At the end of Cycle 2 (Week 14).
Hide Outcome Measure Data
Hide Analysis Population Description
There will be a comparison of the overall tumor response of patients receiving one versus two SBRT doses. Responses from patients who participated in the crossover portion of the study were excluded.
Arm/Group Title Arm A: IL-2 Monotherapy Arm B: SBRT + IL-2
Hide Arm/Group Description:

Patients receive standard high-dose IL-2 therapy, with an opportunity to crossover to the experimental arm if there is disease progression noted after two cycles of high-dose IL-2. Crossover patients will be included in Arm A.

High-dose IL-2: IL-2 will be given on a Monday at a dose of 600,000 IU per kilogram IV every 8 hours for up to 14 doses each cycle. The second cycle is planned 16 days after cycle 1 but may be delayed up to one week to allow toxicity to resolve. The maximum number of doses that can be given during two cycles will be 28 doses. Patients who respond after two cycles can receive 4 more cycles of IL-2. Patients with disease progression after 2 cycles may elect to receive radiation before a 3rd cycle of IL-2. If patients crossover, IL-2 will be given on the Monday following the last dose of radiation, at a dose of 600,000 IU per kilogram IV every 8 hours for a maximum of 14 doses each cycle. Another cycle is planned 16 days after cycle 3 but may be delayed up to one week to allow toxicity to resolve.

Patients 1-20 who are assigned to receive radiation therapy will receive a single dose of radiation before IL-2; patients 21-44 assigned to receive radiation will receive two doses of radiation before receiving high-dose IL-2.

Radiation therapy and high-dose IL-2: Patients 1 - 20 will receive a single fraction of radiation. Patients 21 through the completion of the study will receive two fractions. The dose for all patients will be 20 Gy per fraction to the prescription line at the edge of the planning treatment volume (PTV) with the last dose delivered on a Friday before IL-2 administration. For patients receiving two radiation doses, the doses can be administered on the Wednesday and Friday before IL-2 starts. Patients who are assigned to IL-2 monotherapy and have progressive disease after two IL-2 cycles are then eligible to receive SBRT before cycle 3 of IL-2 commences, single fraction for patients 1-20 and two fractions for patients 21- end of study.
Overall Number of Participants Analyzed 20 24
Measure Type: Number
Unit of Measure: percentage of participants
Overall Response Rate (ORR) 54 35
Complete Response (CR) 15 21
Partial Response (PR) 20 33
Stable Disease (SD) 25 21
Progressive Disease (PD) 40 25
2.Secondary Outcome
Title Response Rate in Crossover Patients
Hide Description Measure the response rate of patients who have disease progression after the first IL-2 cycles (using RECIST criteria) who received SBRT prior to cycle 3 of IL-2.
Time Frame 7 weeks following Cycle 2 (Week 21).
Hide Outcome Measure Data
Hide Analysis Population Description
This measure is specifically for patients enrolled into IL-2 monotherapy cohort who then opted for radiation therapy in addition to IL-2.
Arm/Group Title Arm A: IL-2 Monotherapy Arm B: SBRT + IL-2
Hide Arm/Group Description:

Patients receive standard high-dose IL-2 therapy, with an opportunity to crossover to the experimental arm if there is disease progression noted after two cycles of high-dose IL-2. Crossover patients will be included in Arm A.

High-dose IL-2: IL-2 will be given on a Monday at a dose of 600,000 IU per kilogram IV every 8 hours for up to 14 doses each cycle. The second cycle is planned 16 days after cycle 1 but may be delayed up to one week to allow toxicity to resolve. The maximum number of doses that can be given during two cycles will be 28 doses. Patients who respond after two cycles can receive 4 more cycles of IL-2. Patients with disease progression after 2 cycles may elect to receive radiation before a 3rd cycle of IL-2. If patients crossover, IL-2 will be given on the Monday following the last dose of radiation, at a dose of 600,000 IU per kilogram IV every 8 hours for a maximum of 14 doses each cycle. Another cycle is planned 16 days after cycle 3 but may be delayed up to one week to allow toxicity to resolve.

Patients 1-20 who are assigned to receive radiation therapy will receive a single dose of radiation before IL-2; patients 21-44 assigned to receive radiation will receive two doses of radiation before receiving high-dose IL-2.

Radiation therapy and high-dose IL-2: Patients 1 - 20 will receive a single fraction of radiation. Patients 21 through the completion of the study will receive two fractions. The dose for all patients will be 20 Gy per fraction to the prescription line at the edge of the planning treatment volume (PTV) with the last dose delivered on a Friday before IL-2 administration. For patients receiving two radiation doses, the doses can be administered on the Wednesday and Friday before IL-2 starts. Patients who are assigned to IL-2 monotherapy and have progressive disease after two IL-2 cycles are then eligible to receive SBRT before cycle 3 of IL-2 commences, single fraction for patients 1-20 and two fractions for patients 21- end of study.
Overall Number of Participants Analyzed 7 0
Measure Type: Number
Unit of Measure: Count of participants
CR 1
PR 2
SD 0
PD 4
Time Frame Screening through Week 7 (or 8 if IL-2 restaging) and during the optional crossover phase, up to 7 weeks.
Adverse Event Reporting Description All adverse events reported during the course of the study.
 
Arm/Group Title Arm A: IL-2 Monotherapy Arm B: SBRT + IL-2
Hide Arm/Group Description

Patients receive standard high-dose IL-2 therapy, with an opportunity to crossover to the experimental arm if there is disease progression noted after two cycles of high-dose IL-2. Crossover patients will be included in Arm A.

High-dose IL-2: IL-2 will be given on a Monday at a dose of 600,000 IU per kilogram IV every 8 hours for up to 14 doses each cycle. The second cycle is planned 16 days after cycle 1 but may be delayed up to one week to allow toxicity to resolve. The maximum number of doses that can be given during two cycles will be 28 doses. Patients who respond after two cycles can receive 4 more cycles of IL-2. Patients with disease progression after 2 cycles may elect to receive radiation before a 3rd cycle of IL-2. If patients crossover, IL-2 will be given on the Monday following the last dose of radiation, at a dose of 600,000 IU per kilogram IV every 8 hours for a maximum of 14 doses each cycle. Another cycle is planned 16 days after cycle 3 but may be delayed up to one week to allow toxicity to resolve.

Patients 1-20 who are assigned to receive radiation therapy will receive a single dose of radiation before IL-2; patients 21-44 assigned to receive radiation will receive two doses of radiation before receiving high-dose IL-2.

Radiation therapy and high-dose IL-2: Patients 1 - 20 will receive a single fraction of radiation. Patients 21 through the completion of the study will receive two fractions. The dose for all patients will be 20 Gy per fraction to the prescription line at the edge of the planning treatment volume (PTV) with the last dose delivered on a Friday before IL-2 administration. For patients receiving two radiation doses, the doses can be administered on the Wednesday and Friday before IL-2 starts. Patients who are assigned to IL-2 monotherapy and have progressive disease after two IL-2 cycles are then eligible to receive SBRT before cycle 3 of IL-2 commences, single fraction for patients 1-20 and two fractions for patients 21- end of study.

Patients 25-31 are those who participated in the optional crossover period from Arm A and are included in the at risk figure.
All-Cause Mortality
Arm A: IL-2 Monotherapy Arm B: SBRT + IL-2
Affected / at Risk (%) Affected / at Risk (%)
Total   16/20 (80.00%)      18/31 (58.06%)    
Hide Serious Adverse Events
Arm A: IL-2 Monotherapy Arm B: SBRT + IL-2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/20 (85.00%)      17/31 (54.84%)    
Blood and lymphatic system disorders     
Thrombocytopenia †  1/20 (5.00%)  1 0/31 (0.00%)  0
Cardiac disorders     
Cardiac Arrest †  0/20 (0.00%)  0 1/31 (3.23%)  1
Tachycardia †  1/20 (5.00%)  1 3/31 (9.68%)  4
Chest Pain, Severe †  1/20 (5.00%)  1 0/31 (0.00%)  0
Atrial Fibrillation †  0/20 (0.00%)  0 2/31 (6.45%)  2
Sinus Tachycardia †  1/20 (5.00%)  1 0/31 (0.00%)  0
Ear and labyrinth disorders     
Vertigo †  1/20 (5.00%)  1 0/31 (0.00%)  0
Gastrointestinal disorders     
Diarrhea †  3/20 (15.00%)  3 3/31 (9.68%)  3
Nausea †  2/20 (10.00%)  2 1/31 (3.23%)  1
Vomiting †  1/20 (5.00%)  1 0/31 (0.00%)  0
General disorders     
Azotemia †  0/20 (0.00%)  0 1/31 (3.23%)  1
Fatigue †  1/20 (5.00%)  2 0/31 (0.00%)  0
Malaise †  1/20 (5.00%)  2 0/31 (0.00%)  0
Rigors †  0/20 (0.00%)  0 1/31 (3.23%)  1
Immune system disorders     
Systemic Inflammatory Repsonse †  1/20 (5.00%)  1 0/31 (0.00%)  0
Infections and infestations     
Sepsis †  0/20 (0.00%)  0 1/31 (3.23%)  2
Injury, poisoning and procedural complications     
Left proximal femoral replacement †  1/20 (5.00%)  1 0/31 (0.00%)  0
Investigations     
Lymphocyte Count Decreased †  17/20 (85.00%)  30 17/31 (54.84%)  29
Platelet Count Decreased †  3/20 (15.00%)  5 4/31 (12.90%)  4
Alkaline phosphatase increased †  3/20 (15.00%)  3 0/31 (0.00%)  0
ALT Increased †  2/20 (10.00%)  2 1/31 (3.23%)  2
Bilirubin increased †  6/20 (30.00%)  7 7/31 (22.58%)  8
Troponin Increased †  0/20 (0.00%)  0 1/31 (3.23%)  1
Weight Loss †  0/20 (0.00%)  0 1/31 (3.23%)  1
White Blood Cells Decreased †  1/20 (5.00%)  1 0/31 (0.00%)  0
Metabolism and nutrition disorders     
Hyperuricemia †  1/20 (5.00%)  1 2/31 (6.45%)  2
Hypophosphatemia †  5/20 (25.00%)  8 10/31 (32.26%)  14
Hyperkalemia †  0/20 (0.00%)  0 1/31 (3.23%)  1
Hypoalbuminemia †  0/20 (0.00%)  0 1/31 (3.23%)  1
Hypocalcemia †  1/20 (5.00%)  1 1/31 (3.23%)  1
Hypokalemia †  0/20 (0.00%)  0 3/31 (9.68%)  4
Hyponatremia †  3/20 (15.00%)  4 5/31 (16.13%)  8
Metabolic Acidosis †  0/20 (0.00%)  0 1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders     
Arthralgias †  1/20 (5.00%)  1 1/31 (3.23%)  1
Nervous system disorders     
Acute Ischemic Stroke †  1/20 (5.00%)  1 0/31 (0.00%)  0
Neuropathy, hands †  0/20 (0.00%)  0 1/31 (3.23%)  1
Somnolence †  0/20 (0.00%)  0 1/31 (3.23%)  1
Psychiatric disorders     
Confusion †  0/20 (0.00%)  0 1/31 (3.23%)  1
Renal and urinary disorders     
Creatinine Increased †  5/20 (25.00%)  5 9/31 (29.03%)  11
Respiratory, thoracic and mediastinal disorders     
Hypoxemia †  0/20 (0.00%)  0 2/31 (6.45%)  3
Radiation Pneumonitis †  0/20 (0.00%)  0 1/31 (3.23%)  2
Carbon Dioxide Decreased †  0/20 (0.00%)  0 1/31 (3.23%)  1
Dyspnea †  1/20 (5.00%)  1 0/31 (0.00%)  0
Skin and subcutaneous tissue disorders     
Itching †  1/20 (5.00%)  2 0/31 (0.00%)  0
Pruritis †  1/20 (5.00%)  1 0/31 (0.00%)  0
Vascular disorders     
Hypotension †  13/20 (65.00%)  19 12/31 (38.71%)  21
Acute Occlusive Thrombus †  1/20 (5.00%)  1 0/31 (0.00%)  0
Pulmonary Emboli †  0/20 (0.00%)  0 1/31 (3.23%)  1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A: IL-2 Monotherapy Arm B: SBRT + IL-2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/20 (10.00%)      0/31 (0.00%)    
Blood and lymphatic system disorders     
Anemia †  2/20 (10.00%)  2 0/31 (0.00%)  0
Bilirubin Increased/Elevated †  1/20 (5.00%)  1 0/31 (0.00%)  0
Cardiac disorders     
Tachycardia †  1/20 (5.00%)  1 0/31 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain †  1/20 (5.00%)  1 0/31 (0.00%)  0
Constipation †  1/20 (5.00%)  1 0/31 (0.00%)  0
Diarrhea †  1/20 (5.00%)  1 0/31 (0.00%)  0
Mucositis †  2/20 (10.00%)  2 0/31 (0.00%)  0
Pain, abdominal †  2/20 (10.00%)  2 0/31 (0.00%)  0
General disorders     
Chills †  1/20 (5.00%)  1 0/31 (0.00%)  0
Edema, lower extremity †  1/20 (5.00%)  1 0/31 (0.00%)  0
Fatigue †  1/20 (5.00%)  1 0/31 (0.00%)  0
Azotemia †  1/20 (5.00%)  1 0/31 (0.00%)  0
Injury, poisoning and procedural complications     
Dry Desquamation †  1/20 (5.00%)  1 0/31 (0.00%)  0
Investigations     
Alkaline Phosphate Increased †  2/20 (10.00%)  2 0/31 (0.00%)  0
ALT (SGPT) Increased †  2/20 (10.00%)  2 0/31 (0.00%)  0
AST (SGOT) Increased †  2/20 (10.00%)  2 0/31 (0.00%)  0
Creatinine Increased †  1/20 (5.00%)  1 0/31 (0.00%)  0
Oliguria †  1/20 (5.00%)  1 0/31 (0.00%)  0
Platelet count decreased †  1/20 (5.00%)  1 0/31 (0.00%)  0
White Blood Cells Decreased †  2/20 (10.00%)  2 0/31 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia †  2/20 (10.00%)  2 0/31 (0.00%)  0
Arthralgia †  1/20 (5.00%)  1 0/31 (0.00%)  0
Hyperglycemia †  2/20 (10.00%)  2 0/31 (0.00%)  0
Hypocalcemia †  1/20 (5.00%)  1 0/31 (0.00%)  0
Hypokalemia †  1/20 (5.00%)  1 0/31 (0.00%)  0
Hypomagnesemia †  2/20 (10.00%)  2 0/31 (0.00%)  0
Hyponatremia †  2/20 (10.00%)  2 0/31 (0.00%)  0
Hypophosphatemia †  1/20 (5.00%)  1 0/31 (0.00%)  0
Metabolic acidosis †  2/20 (10.00%)  2 0/31 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Myalgias †  1/20 (5.00%)  1 0/31 (0.00%)  0
Pain, knee †  1/20 (5.00%)  1 0/31 (0.00%)  0
Nervous system disorders     
Dizziness †  1/20 (5.00%)  1 0/31 (0.00%)  0
Drowsiness †  1/20 (5.00%)  1 0/31 (0.00%)  0
Psychiatric disorders     
Confusion †  2/20 (10.00%)  2 0/31 (0.00%)  0
Hallucinations †  1/20 (5.00%)  1 0/31 (0.00%)  0
Vivid Dreams †  1/20 (5.00%)  1 0/31 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough †  1/20 (5.00%)  1 0/31 (0.00%)  0
Skin and subcutaneous tissue disorders     
Erythroderma †  2/20 (10.00%)  2 0/31 (0.00%)  0
Skin, Itching †  1/20 (5.00%)  1 0/31 (0.00%)  0
Vitiligo, upper extremity †  1/20 (5.00%)  1 0/31 (0.00%)  0
Vascular disorders     
Capillary leak pulmonary †  1/20 (5.00%)  1 0/31 (0.00%)  0
†
Indicates events were collected by systematic assessment
[Not Specified]
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: Brendan Curti, M.D.
Organization: Earle A. Chiles Research Institute, Providence Cancer Institute
Phone: 503-215-6588
EMail: brendan.curti@providence.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT01416831    
Other Study ID Numbers: 11-062A
First Submitted: August 12, 2011
First Posted: August 15, 2011
Results First Submitted: May 16, 2022
Results First Posted: November 15, 2022
Last Update Posted: March 27, 2023