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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00055237
First received: February 21, 2003
Last updated: July 30, 2012
Last verified: July 2012
Results First Received: June 19, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Kaposi's Sarcoma
HIV Infections
HIV Seronegativity
Intervention: Biological: Bevacizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected) 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks

Participant Flow:   Overall Study
    Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma     Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)  
STARTED     17     2  
COMPLETED     17     2  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected) 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
Total Total of all reporting groups

Baseline Measures
    Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma     Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)     Total  
Number of Participants  
[units: participants]
  17     2     19  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     2     17  
>=65 years     2     0     2  
Age  
[units: years]
Mean ± Standard Deviation
  42  ± 9.3     58  ± 12.7     50  ± 11  
Gender  
[units: participants]
     
Female     1     0     1  
Male     16     2     18  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     3     0     3  
Not Hispanic or Latino     14     2     16  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     17     2     19  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: 36 months ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 70 months ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Cohort 1 & 2: Pts With HIV-associated and Classic KS 15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks

Other Adverse Events
    Cohort 1 & 2: Pts With HIV-associated and Classic KS  
Total, other (not including serious) adverse events    
# participants affected / at risk     19/19  
Blood and lymphatic system disorders    
Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other) † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     2  
Hemorrhage-Other (Specify, gums; gums bleeding) † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     2  
Platelets † 1  
# participants affected / at risk     11/19 (57.89%)  
# events     25  
Cardiac disorders    
Palpitations † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Cardiac left ventricular function † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Cardiac troponin I (cTnI) † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Ear and labyrinth disorders    
Auditory/Hearing-Other (Specify, hearing loss) † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Endocrine disorders    
Hypothyroidism † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Eye disorders    
Dry eye † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Vision-blurred vision † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Vision-flashing lights/floaters † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Gastrointestinal disorders    
Abdominal pain or cramping † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Anorexia † 1  
# participants affected / at risk     2/19 (10.53%)  
# events     2  
Constipation † 1  
# participants affected / at risk     5/19 (26.32%)  
# events     6  
Diarrhea patients without colostomy † 1  
# participants affected / at risk     9/19 (47.37%)  
# events     17  
Gastrointestinal-Other (Specify, bloating fullness; slight indigestion) † 1  
# participants affected / at risk     2/19 (10.53%)  
# events     2  
Mouth dryness † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Nausea † 1  
# participants affected / at risk     6/19 (31.58%)  
# events     7  
Rectal bleeding/hematochezia † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Vomiting † 1  
# participants affected / at risk     6/19 (31.58%)  
# events     7  
General disorders    
Edema † 1  
# participants affected / at risk     3/19 (15.79%)  
# events     5  
Fatigue (lethargy, malaise, asthenia) † 1  
# participants affected / at risk     5/19 (26.32%)  
# events     9  
Fever † 1 [3]  
# participants affected / at risk     9/19 (47.37%)  
# events     13  
Pain-Other (back pain;leg pain; heel pain; throat pain; from leg cellulitis; in R posterior knee) † 1 [4]  
# participants affected / at risk     10/19 (52.63%)  
# events     27  
Rigors, chills † 1  
# participants affected / at risk     2/19 (10.53%)  
# events     2  
Immune system disorders    
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) † 1  
# participants affected / at risk     8/19 (42.11%)  
# events     10  
Infections and infestations    
Infection without neutropenia † 1  
# participants affected / at risk     3/19 (15.79%)  
# events     5  
Infection/Febrile Neutropenia-Other (Specify) † 1 [5]  
# participants affected / at risk     2/19 (10.53%)  
# events     4  
Investigations    
Alkaline phosphatase † 1  
# participants affected / at risk     2/19 (10.53%)  
# events     8  
Amylase † 1  
# participants affected / at risk     9/19 (47.37%)  
# events     20  
Bilirubin † 1  
# participants affected / at risk     11/19 (57.89%)  
# events     26  
CPK (creatine phosphokinase) † 1  
# participants affected / at risk     8/19 (42.11%)  
# events     27  
Creatinine † 1  
# participants affected / at risk     3/19 (15.79%)  
# events     6  
Hemoglobin † 1  
# participants affected / at risk     10/19 (52.63%)  
# events     31  
Leukocytes (total WBC) † 1  
# participants affected / at risk     8/19 (42.11%)  
# events     33  
Lipase † 1  
# participants affected / at risk     3/19 (15.79%)  
# events     7  
Lymphopenia † 1  
# participants affected / at risk     4/19 (21.05%)  
# events     11  
Neutrophils/granulocytes (ANC/AGC) † 1 [6]  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Partial thromboplastin time (PTT) † 1  
# participants affected / at risk     10/19 (52.63%)  
# events     16  
Prothrombin time (PT) † 1  
# participants affected / at risk     6/19 (31.58%)  
# events     10  
SGOT (AST) (serum glutamic oxaloacetic transaminase) † 1  
# participants affected / at risk     13/19 (68.42%)  
# events     45  
SGPT (ALT) (serum glutamic pyruvic transaminase) † 1  
# participants affected / at risk     8/19 (42.11%)  
# events     22  
Weight loss † 1  
# participants affected / at risk     2/19 (10.53%)  
# events     2  
CD4 count † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Neutrophils/granulocytes (ANC/AGC) † 1 [7]  
# participants affected / at risk     13/19 (68.42%)  
# events     54  
Metabolism and nutrition disorders    
Hypercalcemia † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Hypercholesterolemia † 1  
# participants affected / at risk     3/19 (15.79%)  
# events     4  
Hyperglycemia † 1  
# participants affected / at risk     8/19 (42.11%)  
# events     37  
Hyperkalemia † 1  
# participants affected / at risk     2/19 (10.53%)  
# events     2  
Hypermagnesemia † 1  
# participants affected / at risk     4/19 (21.05%)  
# events     8  
Hypertriglyceridemia † 1  
# participants affected / at risk     3/19 (15.79%)  
# events     7  
Hyperuricemia † 1  
# participants affected / at risk     3/19 (15.79%)  
# events     10  
Hypoalbuminemia † 1  
# participants affected / at risk     13/19 (68.42%)  
# events     48  
Hypocalcemia † 1  
# participants affected / at risk     7/19 (36.84%)  
# events     25  
Hypoglycemia † 1  
# participants affected / at risk     5/19 (26.32%)  
# events     8  
Hypokalemia † 1  
# participants affected / at risk     2/19 (10.53%)  
# events     9  
Hypomagnesemia † 1  
# participants affected / at risk     8/19 (42.11%)  
# events     17  
Hyponatremia † 1  
# participants affected / at risk     12/19 (63.16%)  
# events     46  
Hypophosphatemia † 1  
# participants affected / at risk     8/19 (42.11%)  
# events     21  
Musculoskeletal and connective tissue disorders    
Musculoskeletal-Other (Specify, joint stiffness) † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Myalgia (muscle pain) † 1  
# participants affected / at risk     5/19 (26.32%)  
# events     8  
Arthralgia (joint pain) † 1  
# participants affected / at risk     4/19 (21.05%)  
# events     7  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Tumor pain (onset or exacerbation of tumor pain due to treatment) † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Nervous system disorders    
Dizziness/lightheadedness † 1  
# participants affected / at risk     2/19 (10.53%)  
# events     2  
Headache † 1  
# participants affected / at risk     11/19 (57.89%)  
# events     30  
Neuropathy-sensory † 1  
# participants affected / at risk     4/19 (21.05%)  
# events     6  
Taste disturbance (dysgeusia) † 1  
# participants affected / at risk     2/19 (10.53%)  
# events     2  
Neuropathy - cranial † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Psychiatric disorders    
Insomnia † 1  
# participants affected / at risk     3/19 (15.79%)  
# events     4  
Confusion † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Renal and urinary disorders    
Dysuria (painful urination) † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Hematuria (in the absence of vaginal bleeding) † 1  
# participants affected / at risk     8/19 (42.11%)  
# events     10  
Hemoglobinuria † 1  
# participants affected / at risk     10/19 (52.63%)  
# events     23  
Proteinuria † 1  
# participants affected / at risk     14/19 (73.68%)  
# events     56  
Reproductive system and breast disorders    
Gynecomastia † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Vaginal bleeding † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Respiratory, thoracic and mediastinal disorders    
Cough † 1  
# participants affected / at risk     9/19 (47.37%)  
# events     15  
Dyspnea (shortness of breath) † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Epistaxis † 1  
# participants affected / at risk     8/19 (42.11%)  
# events     12  
Pulmonary-Other (Specify, sneezing) † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Skin and subcutaneous tissue disorders    
Dermatology/Skin-Other (Specify, foot callous; burning sensation in abdominal area) † 1  
# participants affected / at risk     2/19 (10.53%)  
# events     2  
Pigmentation changes (e.g., vitiligo) † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Pruritus † 1  
# participants affected / at risk     2/19 (10.53%)  
# events     3  
Rash/desquamation † 1  
# participants affected / at risk     4/19 (21.05%)  
# events     7  
Sweating (diaphoresis) † 1  
# participants affected / at risk     5/19 (26.32%)  
# events     5  
Dry skin † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Nail changes † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Vascular disorders    
Hypertension † 1  
# participants affected / at risk     10/19 (52.63%)  
# events     18  
Phlebitis (superficial) † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Thrombosis/embolism † 1  
# participants affected / at risk     1/19 (5.26%)  
# events     1  
Events were collected by systematic assessment
1 Term from vocabulary, CTCv2.0
[3] (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
[4] 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
[5] fungal infections, feet tinea pedis; URI; swelling behind R knee; tinea L axilla
[6] for leukemia studies or bone marrow infiltrative/myelophthisic process, if specified in the protocol.
[7] Neutrophils/granulocytes (ANC/AGC) for leukemia studies or bone marrow infiltrative/myelophthisic process, if specified in the protocol.



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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Robert Yarchoan, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-0328
e-mail: Robert.Yarchoan@nih.gov


Publications of Results:

Responsible Party: Robert Yarchoan, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00055237     History of Changes
Obsolete Identifiers: NCT00058136
Other Study ID Numbers: 030110, 03-C-0110
Study First Received: February 21, 2003
Results First Received: June 19, 2012
Last Updated: July 30, 2012
Health Authority: United States: Federal Government