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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: | NCT00020683 |
RATIONALE: COL-3 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of COL-3 in treating patients who have HIV-related Kaposi's sarcoma.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: COL-3 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's Sarcoma |
Study Start Date: | April 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed.
Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study within 1.75 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven Kaposi's sarcoma (KS) involving the skin, lymph nodes, oral cavity, gastrointestinal (GI) tract, and/or lungs
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Washington | |
Virginia Mason Medical Center | |
Seattle, Washington, United States, 98101 |
Study Chair: | Bruce J. Dezube, MD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | CDR0000068703, AMC-027 |
Study First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00020683 |
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 |