Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
This study has been completed.
Sponsor:
SUGEN
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002226
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 2000
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Sarcoma, Kaposi HIV Infections |
Drug: SU5416 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Classic Kaposi Sarcoma
Malignant Mesenchymal Tumor
Soft Tissue Sarcoma
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| Estimated Enrollment: | 30 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002226
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002226
Locations
| United States, California | |
| Norris Cancer Ctr / USC | |
| Los Angeles, California, United States, 90033 | |
| UCLA Care Ctr / Ctr for Hlth Sciences | |
| Los Angeles, California, United States, 900951793 | |
| Saint Francis Mem Hosp / HIV Care Unit | |
| San Francisco, California, United States, 94109 | |
| United States, New York | |
| New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
Sponsors and Collaborators
SUGEN
More Information
Publications:
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
| ClinicalTrials.gov Identifier: | NCT00002226 History of Changes |
| Other Study ID Numbers: | 294A, 5416.003 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Skin Neoplasms Sarcoma, Kaposi Antineoplastic Agents |
Additional relevant MeSH terms:
|
Sarcoma Sarcoma, Kaposi DNA Virus Infections Herpesviridae Infections Neoplasms |
Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Vascular Tissue Virus Diseases |
ClinicalTrials.gov processed this record on March 01, 2015