Back to resultsSafety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
Primary Purpose
Sarcoma, Kaposi, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SU5416
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Skin Neoplasms, Sarcoma, Kaposi, Antineoplastic Agents
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are at least 18 years old. Are HIV-positive. Have KS with at least 5 skin lesions. Have been in stable condition for at least 6 weeks prior to study entry, if receiving antiretroviral therapy. Agree to use effective methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: Have had surgery within 4 weeks of study entry. Have taken certain medications, including therapy for KS, within 3 weeks prior to study entry. Have pulmonary KS (KS in your lungs). Have certain serious medical conditions, including liver or kidney problems, certain infections, and certain cancers. Are allergic to Cremophor. Have not recovered from previous cancer treatment (chemotherapy, radiotherapy, or immunotherapy). Are pregnant.
Sites / Locations
- Norris Cancer Ctr / USC
- UCLA Care Ctr / Ctr for Hlth Sciences
- Saint Francis Mem Hosp / HIV Care Unit
- New York Univ Med Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002226
Brief Title
Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
Official Title
A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2000
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
SUGEN
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to see if it is safe and effective to give SU5416 to HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth of KS tumors.
Detailed Description
Groups of 3-6 patients are sequentially assigned to receive escalating doses of SU5416 in 33% increments. Study drug is administered as a twice-weekly intravenous injection for 4 weeks. In the absence of unacceptable toxicity, responding patients may continue on SU5416 in 4-week treatment cycles for a maximum of 1 year or until the presence of unacceptable toxicity or tumor progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Skin Neoplasms, Sarcoma, Kaposi, Antineoplastic Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SU5416
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
Are at least 18 years old.
Are HIV-positive.
Have KS with at least 5 skin lesions.
Have been in stable condition for at least 6 weeks prior to study entry, if receiving antiretroviral therapy.
Agree to use effective methods of birth control during the study.
Exclusion Criteria
You will not be eligible for this study if you:
Have had surgery within 4 weeks of study entry.
Have taken certain medications, including therapy for KS, within 3 weeks prior to study entry.
Have pulmonary KS (KS in your lungs).
Have certain serious medical conditions, including liver or kidney problems, certain infections, and certain cancers.
Are allergic to Cremophor.
Have not recovered from previous cancer treatment (chemotherapy, radiotherapy, or immunotherapy).
Are pregnant.
Facility Information:
Facility Name
Norris Cancer Ctr / USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Care Ctr / Ctr for Hlth Sciences
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951793
Country
United States
Facility Name
Saint Francis Mem Hosp / HIV Care Unit
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Gill P, Arasteh K, Jacobs M, Friedman-Kiel A, Miles S, Gracey S, Hannah A, Langecker P. A multicenter, dose-escalating study in patients with AIDS-related Kaposi's Sarcoma 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29
Results Reference
background
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Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
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