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Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma

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ClinicalTrials.gov Identifier: NCT01057121
Recruitment Status : Completed
First Posted : January 27, 2010
Results First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions AIDS-Related Kaposi Sarcoma
Recurrent Kaposi Sarcoma
Intervention Drug: Lenalidomide
Enrollment 38

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I: Treatment (Lenalidomide) , 10 mg/Day Phase I: Treatment (Lenalidomide), 15 mg/Day Phase I, Treatment Ienalidomide), 20 mg/Day Phase I: Treatment (Lenalidomide), 25 mg/Day Phase II: Treatment (Lenalidomide), 25 mg/Day
Hide Arm/Group Description Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Phase I: 10 mg/Day Lenalidomide
Started 3 0 0 0 0
Completed 3 0 0 0 0
Not Completed 0 0 0 0 0
Period Title: Phase I: 15 mg/Day Lenolidomide
Started 0 3 0 0 0
Completed 0 3 0 0 0
Not Completed 0 0 0 0 0
Period Title: Phase I: 20 mg/Day Lenalidomide
Started 0 0 3 0 0
Completed 0 0 3 0 0
Not Completed 0 0 0 0 0
Period Title: Phase I: 25 mg/Day Lenalidomide
Started 0 0 0 6 0
Completed 0 0 0 6 0
Not Completed 0 0 0 0 0
Period Title: Phase II: 25 mg/Day Lenalidomide
Started 0 0 0 0 23
Completed 0 0 0 0 23
Not Completed 0 0 0 0 0
Arm/Group Title Phase I - Treatment (Lenalidomide) Phase II - Treatment (Lenalidomide) Total
Hide Arm/Group Description

Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Total of all reporting groups
Overall Number of Baseline Participants 15 23 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 23 participants 38 participants
47.2  (11.8) 46.9  (8.2) 47.0  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 23 participants 38 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
15
 100.0%
23
 100.0%
38
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 23 participants 38 participants
Hispanic or Latino
4
  26.7%
4
  17.4%
8
  21.1%
Not Hispanic or Latino
11
  73.3%
18
  78.3%
29
  76.3%
Unknown or Not Reported
0
   0.0%
1
   4.3%
1
   2.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 23 participants 38 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   6.7%
0
   0.0%
1
   2.6%
Native Hawaiian or Other Pacific Islander
1
   6.7%
1
   4.3%
2
   5.3%
Black or African American
1
   6.7%
5
  21.7%
6
  15.8%
White
12
  80.0%
14
  60.9%
26
  68.4%
More than one race
0
   0.0%
2
   8.7%
2
   5.3%
Unknown or Not Reported
0
   0.0%
1
   4.3%
1
   2.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 23 participants 38 participants
15 23 38
1.Primary Outcome
Title Maximum Tolerated Dose of Lenalidomide Defined as the Dose Level at Which 0/6 or 1/6 Subjects Experience Dose Limiting Toxicity (DLT) With the Next Higher Dose Having at Least 2/3 or 2/6 Subjects Encountering DLT (Phase I)
Hide Description Maximum tolerated dose (MTD) of lenalidomide defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the MTD is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients in the phase I portion of the study were evaluated for this outcome measure.
Arm/Group Title Phase I - Treatment (Lenalidomide)
Hide Arm/Group Description:

Phase I: Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles This arm includes patients treated at the 10 mg/day dose (N=3), 15 mg/day dose (N=3), 20 mg/day dose (N=3) and 25 mg/day dose (N=6)

Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: mg per day of lenalidomide
25
2.Primary Outcome
Title Tumor Response Rate
Hide Description

Percentage of patients who achieve a partial or complete response Complete response was defined as the absence of any detectable residual disease, including tumor-associated edema, that persisted for at least 4 weeks.

Partial response was defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions that lasted for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions.

Time Frame Up to 30 days after completion of study treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who were evaluable for response. To be evaluable for response, the patient had to complete at least one cycle of treatment.
Arm/Group Title Phase I - 10 mg/Day (Lenalidomide) Phase I - 15 mg/Day (Lenalidomide) Phase I: 20 mg/Day Lenalidomide Phase I: 25 mg/Day Lenalidomide Phase II: 25 mg/Day Lenalidomide
Hide Arm/Group Description:

Patients received 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients received 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Overall Number of Participants Analyzed 3 3 2 5 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants who responded
0
(0 to 0)
0
(0 to 0)
50
(1 to 99)
80
(28 to 99)
53
(30 to 75)
3.Secondary Outcome
Title Time to Death
Hide Description Percentage of patients who died
Time Frame Up to 30 days after completion of study treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study participants who died on study.
Arm/Group Title Phase I - 10 mg/Day Lenalidomide Phase I - 15 mg/Day Lenalidomide Phase I: 20 mg/Day Lenalidomide Phase I: 25 mg/Day Lenalidomide Phase II: 25 mg/Day Lenalidomide
Hide Arm/Group Description:

Patients received 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients received lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Overall Number of Participants Analyzed 3 3 3 6 23
Measure Type: Number
Unit of Measure: percentage of participants who died
0 0 0 0 0
4.Secondary Outcome
Title Time to Relapse
Hide Description Percentage of participants who relapsed
Time Frame Up to 30 days after completion of study treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who relapsed
Arm/Group Title Phase I - 10 mg/Day Treatment (Lenalidomide) Phase I - 15 mg/Dah Treatment (Lenalidomide) Phase I - 20 mg/Day Treatment (Lenalidomide) Phase I: Treatment (Lenalidomide), 25 mg/Day Phase II: 25 m/Day Treatment (Lenalidomide)
Hide Arm/Group Description:

Patients receive 10 mg/day of lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to Response
Hide Description

time from enrollment to first response (complete or partial) as defined below: Complete response is defined as the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks.

Partial response is defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions lasting for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions.

Time Frame Up to 30 days after completion of study treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had a complete or partial responses
Arm/Group Title Phase I - 10 mg/Day Treatment (Lenalidomide) Phase I - 15 mg/Dah Treatment (Lenalidomide) Phase I: 20 mg/Day Treatment (Lenalidomide) Phase I: 25 mg/Day Treatment (Lenalidomide) Phase II: 25 m/Day Treatment (Lenalidomide)
Hide Arm/Group Description:

Patients receive 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Overall Number of Participants Analyzed 0 0 1 4 10
Median (Full Range)
Unit of Measure: weeks
8
(8 to 8)
20.5
(12 to 28)
13
(4 to 38)
6.Other Pre-specified Outcome
Title Relationship Between Clinical Response and Quantitative Measures of Kaposi's Sarcoma-associated Herpesvirus (KSHV)/HHV-8 and HIV Viral Load
Hide Description Spearman rank correlation analysis will be used to evaluate the relationship between the qualification of baseline KSHV/HHV-8, HIV viral load and time to progression, and response duration.
Time Frame Up to 30 days after completion of study treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The KSHV (HHV-8) assays were run, but the results were unreliable.
Arm/Group Title Phase I - Treatment (Lenalidomide) Phase II - Treatment (Lenalidomide)
Hide Arm/Group Description:

Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I: 10 mg/Day Lenalidomide Phase I: 15 mg/Day Lenalidomide Phase I: 20 mg/Day Lenalidomide Phase I and II: 25 mg/Day Lenalidomide
Hide Arm/Group Description

Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

All-Cause Mortality
Phase I: 10 mg/Day Lenalidomide Phase I: 15 mg/Day Lenalidomide Phase I: 20 mg/Day Lenalidomide Phase I and II: 25 mg/Day Lenalidomide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I: 10 mg/Day Lenalidomide Phase I: 15 mg/Day Lenalidomide Phase I: 20 mg/Day Lenalidomide Phase I and II: 25 mg/Day Lenalidomide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)      0/3 (0.00%)      6/29 (20.69%)    
Infections and infestations         
Lung Infection *  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/29 (6.90%)  2
Meningitis *  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1
Skin infection *  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders         
Back pain *  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1
Pain in extremity *  0/3 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1
Nervous system disorders         
Facial nerve disorder *  0/3 (0.00%)  0/3 (0.00%)  0 0/3 (0.00%)  0 1/29 (3.45%)  1
Vascular disorders         
Hypotension *  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/29 (3.45%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I: 10 mg/Day Lenalidomide Phase I: 15 mg/Day Lenalidomide Phase I: 20 mg/Day Lenalidomide Phase I and II: 25 mg/Day Lenalidomide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      28/29 (96.55%)    
Blood and lymphatic system disorders         
Anemia *  0/3 (0.00%)  0 0/3 (0.00%)  2/3 (66.67%)  7/29 (24.14%) 
Blood and Lymphatic disorders, other *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  4/29 (13.79%) 
Gastrointestinal disorders         
Abdominal pain *  2/3 (66.67%)  2 0/3 (0.00%)  0/3 (0.00%)  0/29 (0.00%) 
Constipation *  0/3 (0.00%)  0 1/3 (33.33%)  0/3 (0.00%)  6/29 (20.69%) 
Diarrhea *  0/3 (0.00%)  0 1/3 (33.33%)  1/3 (33.33%)  13/29 (44.83%) 
Dry mouth *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  2/29 (6.90%) 
Dyspepsia *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  2/29 (6.90%) 
Gastroesophageal reflux *  0/3 (0.00%)  0 1/3 (33.33%)  0/3 (0.00%)  1/29 (3.45%) 
Nausea *  1/3 (33.33%)  1 0/3 (0.00%)  0/3 (0.00%)  6/29 (20.69%) 
Vomiting *  0/3 (0.00%)  0 1/3 (33.33%)  0/3 (0.00%)  4/29 (13.79%) 
Salivary duct inflammation *  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/29 (0.00%) 
General disorders         
Edema - limbs *  1/3 (33.33%)  1 0/3 (0.00%)  0/3 (0.00%)  3/29 (10.34%) 
Fatigue *  2/3 (66.67%)  2 0/3 (0.00%)  2/3 (66.67%)  16/29 (55.17%) 
Fever *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  4/29 (13.79%) 
Pain *  1/3 (33.33%)  1 0/3 (0.00%)  0/3 (0.00%)  4/29 (13.79%) 
Immune system disorders         
Allergic reaction *  1/3 (33.33%)  1 0/3 (0.00%)  0/3 (0.00%)  1/29 (3.45%) 
Infections and infestations         
Sinusitis *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  2/29 (6.90%) 
Skin infection *  1/3 (33.33%)  2 0/3 (0.00%)  0/3 (0.00%)  4/29 (13.79%) 
Upper respiratory infection *  1/3 (33.33%)  1 1/3 (33.33%)  0/3 (0.00%)  4/29 (13.79%) 
Investigations         
Alanine aminotransferase increased *  2/3 (66.67%)  2 0/3 (0.00%)  0/3 (0.00%)  4/29 (13.79%) 
Alkaline phosphatase increased *  0/3 (0.00%)  0 0/3 (0.00%)  1/3 (33.33%)  1/29 (3.45%) 
Aspartate aminotransferase increased *  1/3 (33.33%)  1 0/3 (0.00%)  0/3 (0.00%)  4/29 (13.79%) 
Lymphocyte count decreased *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  2/29 (6.90%) 
Neutrophil count decreased *  0/3 (0.00%)  0 1/3 (33.33%)  2/3 (66.67%)  12/29 (41.38%) 
Platelet count decreased *  1/3 (33.33%)  1 1/3 (33.33%)  0/3 (0.00%)  5/29 (17.24%) 
Weight loss *  0/3 (0.00%)  0 0/3 (0.00%)  1/3 (33.33%)  1/29 (3.45%) 
White blood cell decreased *  0/3 (0.00%)  0 0/3 (0.00%)  1/3 (33.33%)  6/29 (20.69%) 
Blood bilirubin increased *  1/3 (33.33%)  2 0/3 (0.00%)  0/3 (0.00%)  0/29 (0.00%) 
Creatinine Increased *  1/3 (33.33%)  1 0/3 (0.00%)  0/3 (0.00%)  0/29 (0.00%) 
Investigations, other *  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/29 (0.00%) 
Metabolism and nutrition disorders         
Anorexia *  1/3 (33.33%)  1 0/3 (0.00%)  0/3 (0.00%)  3/29 (10.34%) 
Hyperglycemia *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  2/29 (6.90%) 
Hypocalcemia *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  3/29 (10.34%) 
Hypoglycemia *  0/3 (0.00%)  0 1/3 (33.33%)  0/3 (0.00%)  1/29 (3.45%) 
Hypophosphatemia *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  3/29 (10.34%) 
Metaolism and nutrition disorders, other *  2/3 (66.67%)  2 0/3 (0.00%)  0/3 (0.00%)  2/29 (6.90%) 
Hypokalemia *  1/3 (33.33%)  1 0/3 (0.00%)  0/3 (0.00%)  0/29 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  2/29 (6.90%) 
Back pain *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  2/29 (6.90%) 
Myalgia *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  4/29 (13.79%) 
Pain in extremity *  0/3 (0.00%)  0 0/3 (0.00%)  1/3 (33.33%)  2/29 (6.90%) 
Nervous system disorders         
Dizziness *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  4/29 (13.79%) 
Headache *  1/3 (33.33%)  1 0/3 (0.00%)  0/3 (0.00%)  8/29 (27.59%) 
Nervous system disorder, other *  0/3 (0.00%)  0 0/3 (0.00%)  1/3 (33.33%)  1/29 (3.45%) 
Peripheral sensory neuropathy *  1/3 (33.33%)  1 0/3 (0.00%)  0/3 (0.00%)  1/29 (3.45%) 
Anxiety *  1/3 (33.33%)  1 0/3 (0.00%)  0/3 (0.00%)  1/29 (3.45%) 
Syncope *  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/29 (0.00%) 
Psychiatric disorders         
Depression *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  3/29 (10.34%) 
Insomnia *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  3/29 (10.34%) 
Respiratory, thoracic and mediastinal disorders         
Cough *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  4/29 (13.79%) 
Dyspnea *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  2/29 (6.90%) 
Nasal congestion *  0/3 (0.00%)  0 0/3 (0.00%)  0/3 (0.00%)  5/29 (17.24%) 
Skin and subcutaneous tissue disorders         
Dry skin *  2/3 (66.67%)  2 1/3 (33.33%)  0/3 (0.00%)  3/29 (10.34%) 
Pruritus *  0/3 (0.00%)  0 1/3 (33.33%)  1/3 (33.33%)  8/29 (27.59%) 
Rash maculo-papular *  0/3 (0.00%)  0 0/3 (0.00%)  2/3 (66.67%)  10/29 (34.48%) 
Skin and subcutaneous tissue disorders, other *  1/3 (33.33%)  1 0/3 (0.00%)  0/3 (0.00%)  6/29 (20.69%) 
Vascular disorders         
Lymphedema *  0/3 (0.00%)  0 1/3 (33.33%)  1/3 (33.33%)  2/29 (6.90%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: AMC Statistical Center
Organization: AIDS Malignancy Consortium
Phone: 501-526-6712
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01057121     History of Changes
Other Study ID Numbers: NCI-2012-02923
NCI-2012-02923 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000664131
AMC-070 ( Other Identifier: AIDS - Associated Malignancies Clinical Trials Consortium )
AMC-070 ( Other Identifier: CTEP )
U01CA121947 ( U.S. NIH Grant/Contract )
First Submitted: January 26, 2010
First Posted: January 27, 2010
Results First Submitted: March 4, 2016
Results First Posted: July 21, 2016
Last Update Posted: July 21, 2016