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Sponsors and Collaborators: |
AIDS Associated Malignancies Clinical Trials Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00024024 |
RATIONALE: Drugs such as BMS-275291 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of BMS-275291 in treating patients who have HIV-related Kaposi's sarcoma.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: BMS-275291 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I-II Trial Of BMS-275291 In Patients With HIV-Related Kaposi's Sarcoma |
Study Start Date: | August 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral BMS-275291 1-2 times daily. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of BMS-275291 until the recommended phase II dose (RPTD) is determined. The RPTD is the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity and more than 1 of 6 patients experiences clinical response or at least 5 of 6 patients demonstrate biologic activity. An additional 29 patients are treated at the RPTD.
Quality of life is assessed on day 15 of the first course and then every 28 days thereafter.
Patients are followed for at least 1 month.
PROJECTED ACCRUAL: Approximately 24-59 patients will be accrued for this study within 12 months.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least 5 measurable lesions
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
Chicago, Illinois, United States, 60611-3013 | |
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Herbert Irving Comprehensive Cancer Center | |
New York, New York, United States, 10032 |
Study Chair: | Jamie Hayden Von Roenn, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000068885, AMC-024, CPMC-IRB-13985 |
Study First Received: | September 13, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00024024 |
Health Authority: | United States: Federal Government |
AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma |
Virus Diseases Neoplasms, Connective and Soft Tissue Kaposi sarcoma HIV Infections Malignant mesenchymal tumor Sarcoma, Kaposi |
Acquired Immunodeficiency Syndrome Sarcoma DNA Virus Infections Soft tissue sarcomas Recurrence Herpesviridae Infections |
Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue |