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Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients

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ClinicalTrials.gov Identifier: NCT00055237
Recruitment Status : Completed
First Posted : February 21, 2003
Results First Posted : July 26, 2012
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Robert Yarchoan, National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Kaposi's Sarcoma
HIV Infections
HIV Seronegativity
Intervention Biological: Bevacizumab
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)
Hide Arm/Group Description 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
Period Title: Overall Study
Started 17 2
Completed 17 2
Not Completed 0 0
Arm/Group Title Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected) Total
Hide Arm/Group Description 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks Total of all reporting groups
Overall Number of Baseline Participants 17 2 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 2 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  88.2%
2
 100.0%
17
  89.5%
>=65 years
2
  11.8%
0
   0.0%
2
  10.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 2 participants 19 participants
42  (9.3) 58  (12.7) 50  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 2 participants 19 participants
Female
1
   5.9%
0
   0.0%
1
   5.3%
Male
16
  94.1%
2
 100.0%
18
  94.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 2 participants 19 participants
Hispanic
3
  17.6%
0
   0.0%
3
  15.8%
Not Hispanic or Latino
14
  82.4%
2
 100.0%
16
  84.2%
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 17 participants 2 participants 19 participants
17 2 19
1.Primary Outcome
Title Response Rate
Hide Description Percentage of participants with a complete response (CR) + partial response (PR)per the Modified AIDS Clinical Trial Group Criteria (ACTG) for HIV-KS. PR is a 50% decrease in the number and/or size of previously existing lesions for 4 weeks; or complete flattening of at least 50% of all previously raised lesions lasting for at least 4 weeks; or a 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions lasting for at least 4 weeks; CR is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort 2 is not reported here because response rate in HIV negative patients was a secondary outcome.
Arm/Group Title Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma
Hide Arm/Group Description:
15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
Overall Number of Participants Analyzed 16
Mean (95% Confidence Interval)
Unit of Measure: Percentage of participants
31
(11 to 58.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method sample estimate with 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion estimate,binomial exact 95%CI
Estimated Value 31
Confidence Interval (2-Sided) 95%
11 to 58.7
Parameter Dispersion
Type: Standard Deviation
Value: 11.6
Estimation Comments As stated in the Outcome statistical Analysis 1. Section, the confidence interval was calculated using binomial exact statistics. The standard deviation is based on that calculation.
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here are the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.
Time Frame 70 months
Hide Outcome Measure Data
Hide Analysis Population Description

All adverse events regardless of attribution, over 202 cycles in 19 patients. Per protocol analysis of adverse events.

Cohort 1 and 2 are reported together.

Arm/Group Title Cohort 1 & 2: Pts With HIV-associated and Classic KS
Hide Arm/Group Description:
15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
19
 100.0%
Time Frame 70 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 & 2: Pts With HIV-associated and Classic KS
Hide Arm/Group Description 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
All-Cause Mortality
Cohort 1 & 2: Pts With HIV-associated and Classic KS
Affected / at Risk (%)
Total   0/19 (0.00%)    
Hide Serious Adverse Events
Cohort 1 & 2: Pts With HIV-associated and Classic KS
Affected / at Risk (%) # Events
Total   4/19 (21.05%)    
Blood and lymphatic system disorders   
Transfusion: Platelets  1  1/19 (5.26%)  1
Gastrointestinal disorders   
Vomit  1  1/19 (5.26%)  1
General disorders   
Syndromes-Other (Specify, toxic shock syndrome)  1  1/19 (5.26%)  1
Infections and infestations   
Infection  1 [1]  1/19 (5.26%)  1
Infection/Febrile Neutropenia-Other (Specify, from leg cellulitis)  1  3/19 (15.79%)  3
Investigations   
Bicarbonate  1  1/19 (5.26%)  1
CPK (creatine phosphokinase)  1  1/19 (5.26%)  1
Creatinine  1  1/19 (5.26%)  1
Hemoglobin  1  1/19 (5.26%)  3
Partial thromboplastin time (PTT)  1  1/19 (5.26%)  1
Platelets  1  1/19 (5.26%)  1
Metabolism and nutrition disorders   
Acidosis (metabolic or respiratory)  1  1/19 (5.26%)  1
Renal and urinary disorders   
Renal failure  1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome (ARDS)  1  1/19 (5.26%)  1
Hypoxia  1  1/19 (5.26%)  1
Vascular disorders   
Hypotension  1  1/19 (5.26%)  1
1
Term from vocabulary, CTCv2.0
Indicates events were collected by systematic assessment
[1]
(documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 & 2: Pts With HIV-associated and Classic KS
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Blood and lymphatic system disorders   
Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)  1  1/19 (5.26%)  2
Hemorrhage-Other (Specify, gums; gums bleeding)  1  1/19 (5.26%)  2
Platelets  1  11/19 (57.89%)  25
Cardiac disorders   
Palpitations  1  1/19 (5.26%)  1
Cardiac left ventricular function  1  1/19 (5.26%)  1
Cardiac troponin I (cTnI)  1  1/19 (5.26%)  1
Ear and labyrinth disorders   
Auditory/Hearing-Other (Specify, hearing loss)  1  1/19 (5.26%)  1
Endocrine disorders   
Hypothyroidism  1  1/19 (5.26%)  1
Eye disorders   
Dry eye  1  1/19 (5.26%)  1
Vision-blurred vision  1  1/19 (5.26%)  1
Vision-flashing lights/floaters  1  1/19 (5.26%)  1
Gastrointestinal disorders   
Abdominal pain or cramping  1  1/19 (5.26%)  1
Anorexia  1  2/19 (10.53%)  2
Constipation  1  5/19 (26.32%)  6
Diarrhea patients without colostomy  1  9/19 (47.37%)  17
Gastrointestinal-Other (Specify, bloating fullness; slight indigestion)  1  2/19 (10.53%)  2
Mouth dryness  1  1/19 (5.26%)  1
Nausea  1  6/19 (31.58%)  7
Rectal bleeding/hematochezia  1  1/19 (5.26%)  1
Vomiting  1  6/19 (31.58%)  7
General disorders   
Edema  1  3/19 (15.79%)  5
Fatigue (lethargy, malaise, asthenia)  1  5/19 (26.32%)  9
Fever  1 [1]  9/19 (47.37%)  13
Pain-Other (back pain;leg pain; heel pain; throat pain; from leg cellulitis; in R posterior knee)  1 [2]  10/19 (52.63%)  27
Rigors, chills  1  2/19 (10.53%)  2
Immune system disorders   
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  8/19 (42.11%)  10
Infections and infestations   
Infection without neutropenia  1  3/19 (15.79%)  5
Infection/Febrile Neutropenia-Other (Specify)  1 [3]  2/19 (10.53%)  4
Investigations   
Alkaline phosphatase  1  2/19 (10.53%)  8
Amylase  1  9/19 (47.37%)  20
Bilirubin  1  11/19 (57.89%)  26
CPK (creatine phosphokinase)  1  8/19 (42.11%)  27
Creatinine  1  3/19 (15.79%)  6
Hemoglobin  1  10/19 (52.63%)  31
Leukocytes (total WBC)  1  8/19 (42.11%)  33
Lipase  1  3/19 (15.79%)  7
Lymphopenia  1  4/19 (21.05%)  11
Neutrophils/granulocytes (ANC/AGC)  1 [4]  1/19 (5.26%)  1
Partial thromboplastin time (PTT)  1  10/19 (52.63%)  16
Prothrombin time (PT)  1  6/19 (31.58%)  10
SGOT (AST) (serum glutamic oxaloacetic transaminase)  1  13/19 (68.42%)  45
SGPT (ALT) (serum glutamic pyruvic transaminase)  1  8/19 (42.11%)  22
Weight loss  1  2/19 (10.53%)  2
CD4 count  1  1/19 (5.26%)  1
Neutrophils/granulocytes (ANC/AGC)  1 [5]  13/19 (68.42%)  54
Metabolism and nutrition disorders   
Hypercalcemia  1  1/19 (5.26%)  1
Hypercholesterolemia  1  3/19 (15.79%)  4
Hyperglycemia  1  8/19 (42.11%)  37
Hyperkalemia  1  2/19 (10.53%)  2
Hypermagnesemia  1  4/19 (21.05%)  8
Hypertriglyceridemia  1  3/19 (15.79%)  7
Hyperuricemia  1  3/19 (15.79%)  10
Hypoalbuminemia  1  13/19 (68.42%)  48
Hypocalcemia  1  7/19 (36.84%)  25
Hypoglycemia  1  5/19 (26.32%)  8
Hypokalemia  1  2/19 (10.53%)  9
Hypomagnesemia  1  8/19 (42.11%)  17
Hyponatremia  1  12/19 (63.16%)  46
Hypophosphatemia  1  8/19 (42.11%)  21
Musculoskeletal and connective tissue disorders   
Musculoskeletal-Other (Specify, joint stiffness)  1  1/19 (5.26%)  1
Myalgia (muscle pain)  1  5/19 (26.32%)  8
Arthralgia (joint pain)  1  4/19 (21.05%)  7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain (onset or exacerbation of tumor pain due to treatment)  1  1/19 (5.26%)  1
Nervous system disorders   
Dizziness/lightheadedness  1  2/19 (10.53%)  2
Headache  1  11/19 (57.89%)  30
Neuropathy-sensory  1  4/19 (21.05%)  6
Taste disturbance (dysgeusia)  1  2/19 (10.53%)  2
Neuropathy - cranial  1  1/19 (5.26%)  1
Psychiatric disorders   
Insomnia  1  3/19 (15.79%)  4
Confusion  1  1/19 (5.26%)  1
Renal and urinary disorders   
Dysuria (painful urination)  1  1/19 (5.26%)  1
Hematuria (in the absence of vaginal bleeding)  1  8/19 (42.11%)  10
Hemoglobinuria  1  10/19 (52.63%)  23
Proteinuria  1  14/19 (73.68%)  56
Reproductive system and breast disorders   
Gynecomastia  1  1/19 (5.26%)  1
Vaginal bleeding  1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  9/19 (47.37%)  15
Dyspnea (shortness of breath)  1  1/19 (5.26%)  1
Epistaxis  1  8/19 (42.11%)  12
Pulmonary-Other (Specify, sneezing)  1  1/19 (5.26%)  1
Skin and subcutaneous tissue disorders   
Dermatology/Skin-Other (Specify, foot callous; burning sensation in abdominal area)  1  2/19 (10.53%)  2
Pigmentation changes (e.g., vitiligo)  1  1/19 (5.26%)  1
Pruritus  1  2/19 (10.53%)  3
Rash/desquamation  1  4/19 (21.05%)  7
Sweating (diaphoresis)  1  5/19 (26.32%)  5
Dry skin  1  1/19 (5.26%)  1
Nail changes  1  1/19 (5.26%)  1
Vascular disorders   
Hypertension  1  10/19 (52.63%)  18
Phlebitis (superficial)  1  1/19 (5.26%)  1
Thrombosis/embolism  1  1/19 (5.26%)  1
1
Term from vocabulary, CTCv2.0
Indicates events were collected by systematic assessment
[1]
(in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
[2]
continued plantar fascilitis;jaw pain;knee pain;local pain foot/leg;pressure R mid back;sore throat;tooth pain;burn L thumb;chest pain;cramps in feet;soreness L index finger;knee-tumor pain;leg pain;side mandibular LN tender; infection,abcess tooth
[3]
fungal infections, feet tinea pedis; URI; swelling behind R knee; tinea L axilla
[4]
for leukemia studies or bone marrow infiltrative/myelophthisic process, if specified in the protocol.
[5]
Neutrophils/granulocytes (ANC/AGC) for leukemia studies or bone marrow infiltrative/myelophthisic process, if specified in the protocol.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Robert Yarchoan, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-0328
EMail: Robert.Yarchoan@nih.gov
Publications of Results:
Uldrick T, Wyvill K, Kumar P, Bernstein W, O'Mahony D, Polizzotto M, Aleman K, Steinberg S, Pittaluga S, Little R, and Yarchoan R. A Phase II Study Targeting Vascular Endothelial Growth Factor with the Humanized Monoclonal Antibody Bevacizumab in the Treatment of Patients with HIV-Associated Kaposi Sarcoma. 17th Conference on Retroviruses and Opportunistic Infections. Oral Presentation. February 17, 2010.
Layout table for additonal information
Responsible Party: Robert Yarchoan, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00055237    
Obsolete Identifiers: NCT00058136
Other Study ID Numbers: 030110
03-C-0110
First Submitted: February 21, 2003
First Posted: February 21, 2003
Results First Submitted: June 19, 2012
Results First Posted: July 26, 2012
Last Update Posted: September 6, 2017