- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002226
Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
June 23, 2005 updated by: SUGEN
A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma
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.
Study Overview
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.
Study Type
Interventional
Enrollment
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90033
- Norris Cancer Ctr / USC
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Los Angeles, California, United States, 900951793
- UCLA Care Ctr / Ctr for Hlth Sciences
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San Francisco, California, United States, 94109
- Saint Francis Mem Hosp / HIV Care Unit
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New York
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New York, New York, United States, 10016
- New York Univ Med Ctr
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
June 1, 2000
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- DNA Virus Infections
- Herpesviridae Infections
- Neoplasms, Vascular Tissue
- Sarcoma
- Sarcoma, Kaposi
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Semaxinib
Other Study ID Numbers
- 294A
- 5416.003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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