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Sponsors and Collaborators: |
Novum National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000954 |
To determine the toxicity and response to treatment with cytotoxic chemotherapy using doxorubicin (Adriamycin), bleomycin, and vincristine (DBV) for advanced AIDS-related Kaposi's sarcoma in combination with either didanosine (ddI) or zalcitabine (dideoxycytidine; ddC).
AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections.
Condition | Intervention | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections |
Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride Drug: Zalcitabine Drug: Didanosine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study of Combination Chemotherapy (Adriamycin, Bleomycin, +/- Vincristine) and Dideoxyinosine (ddI) or Dideoxycytidine (ddC) in the Treatment of AIDS-Related Kaposi's Sarcoma |
Estimated Enrollment: | 72 |
AIDS patients with extensive Kaposi's sarcoma require treatment with effective cytotoxic agents to reduce the tumor burden, and they also require treatment with other possibly effective antiretroviral agents such as ddI or ddC to ameliorate (delay) the development of opportunistic infections.
In Phase I, eligible patients with advanced Kaposi's sarcoma are randomly assigned to either ddI or ddC in combination with DBV chemotherapy. On the average, patients receive 12-44 weeks of combined chemotherapy and antiretroviral therapy. If vincristine is deleted from Phase I because of excess neurotoxicity, it will not be administered as part of the combination chemotherapy if that treatment is continued in the Phase II study. The Phase II trial proceeds when at least six cycles (12 weeks) of DBV have been completed by six patients enrolled in Phase I, and an overall evaluation of tolerance to each combination treatment plan has been completed. Study medication is administered as in Phase I, with the possible deletion of vincristine. All patients who complete DBV chemotherapy with complete or partial response or stable disease will continue to receive the originally assigned investigational antiretroviral drug (ddC or ddI) for an additional 24 weeks.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Patients must have:
For patients < 18 years of age:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions or symptoms are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Alcohol consumption is strongly discouraged.
United States, California | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
Univ of Southern California / LA County USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 900331079 | |
Olive View Med Ctr | |
Sylmar, California, United States, 91342 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
Denver Dept of Health and Hosps | |
Denver, Colorado, United States, 80262 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
United States, Massachusetts | |
Boston Med Ctr | |
Boston, Massachusetts, United States, 02118 | |
United States, New York | |
SUNY - Stony Brook | |
Stony Brook, New York, United States, 117948153 | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Saint Luke's - Roosevelt Hosp Ctr | |
New York, New York, United States, 10025 | |
SUNY / Erie County Med Ctr at Buffalo | |
Buffalo, New York, United States, 14215 | |
Columbia Presbyterian Med Ctr | |
New York, New York, United States, 100323784 | |
Adirondack Med Ctr at Saranac Lake | |
Albany, New York, United States, 122083479 | |
Mid - Hudson Care Ctr | |
Albany, New York, United States, 122083479 | |
Albany Med College / Division of HIV Medicine A158 | |
Albany, New York, United States, 122083479 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
United States, Ohio | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
United States, Pennsylvania | |
Girard Med Ctr | |
Philadelphia, Pennsylvania, United States, 191046073 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 | |
United States, Texas | |
Univ of Texas Galveston | |
Galveston, Texas, United States, 775550435 |
Study Chair: | Mitsuyasu RT | |
Study Chair: | Gill PS |
Study ID Numbers: | ACTG 163 |
Study First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00000954 |
Health Authority: | Unspecified |
Vincristine Sarcoma, Kaposi Zalcitabine Didanosine Doxorubicin Drug Evaluation Drug Interactions |
Drug Therapy, Combination Combined Modality Therapy Acquired Immunodeficiency Syndrome Antineoplastic Agents Antineoplastic Agents, Combined Antiviral Agents Bleomycin |
Sexually Transmitted Diseases, Viral Malignant mesenchymal tumor Zalcitabine Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Vincristine Bleomycin Doxorubicin Soft tissue sarcomas Immunologic Deficiency Syndromes |
Herpesviridae Infections Virus Diseases Neoplasms, Connective and Soft Tissue Kaposi sarcoma Didanosine HIV Infections Sexually Transmitted Diseases Sarcoma DNA Virus Infections Retroviridae Infections |
Antimetabolites Anti-Infective Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antibiotics, Antineoplastic Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Neoplasms, Vascular Tissue Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Neoplasms by Histologic Type Anti-HIV Agents Immune System Diseases Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Antiviral Agents Pharmacologic Actions Neoplasms Tubulin Modulators Lentivirus Infections Antineoplastic Agents, Phytogenic |