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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000987 |
To study the safety and maximum tolerated dose (MTD) of combined chemotherapy when it is administered to patients with advanced Kaposi's sarcoma together with one of two different doses of zidovudine (AZT).
The combination of AZT and chemotherapy may be effective in treating the tumor as well as preventing the life-threatening infections when used for patients with AIDS and Kaposi's sarcoma. The MTD of combined chemotherapy is being determined so that the information will be available for future studies, when the relative effectiveness of the two doses of AZT has been learned.
Condition | Intervention | Phase |
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Sarcoma, Kaposi HIV Infections |
Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride Drug: Zidovudine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison |
Official Title: | A Phase I Study of Combination Chemotherapy (Adriamycin, Bleomycin, and Vincristine) and Azidothymidine in the Treatment of AIDS Related Kaposi's Sarcoma |
Estimated Enrollment: | 36 |
The combination of AZT and chemotherapy may be effective in treating the tumor as well as preventing the life-threatening infections when used for patients with AIDS and Kaposi's sarcoma. The MTD of combined chemotherapy is being determined so that the information will be available for future studies, when the relative effectiveness of the two doses of AZT has been learned.
AMENDED: AZT by mouth. If the treatment is well tolerated, subsequent groups of patients are started on increasing doses of doxorubicin combined with the same dose of bleomycin and vincristine. After determination of the MTD of chemotherapy in combination with AZT, the 2nd phase begins in which AZT is given and the first group of patients is given bleomycin and vincristine only. If this combination is well tolerated, then the subsequent groups are started on increasing doses of doxorubicin with the same dose of bleomycin, vincristine and AZT. The MTD of chemotherapy in combination with AZT is then determined. Patients achieving maximum response to the tumor are maintained on AZT alone. This is an outpatient study, and patients are seen every 2 weeks for evaluation, with a physical examination every month. Original design: The combination of chemotherapy and AZT is given to groups of four patients each, the first group beginning with bleomycin and vincristine, without the addition of doxorubicin. The chemotherapy is given intravenously every 2 weeks. This is combined first with AZT by mouth.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must demonstrate any of the following clinical and laboratory findings:
Patients with any of the following constitutional symptoms with no etiology established may be included:
Active alcohol or drug abuse sufficient to prevent adequate compliance with study therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions will be excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
United States, California | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
USC School of Medicine / Norris Cancer Hosp | |
Los Angeles, California, United States, 90033 |
Study Chair: | PS Gill | |
Study Chair: | S Miles |
Study ID Numbers: | ACTG 075 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000987 |
Health Authority: | United States: Federal Government |
Vincristine Doxorubicin Drug Therapy, Combination |
Acquired Immunodeficiency Syndrome Zidovudine Bleomycin |
Sexually Transmitted Diseases, Viral Malignant mesenchymal tumor Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Vincristine Zidovudine Bleomycin Doxorubicin Soft tissue sarcomas Immunologic Deficiency Syndromes |
Herpesviridae Infections Virus Diseases Neoplasms, Connective and Soft Tissue Kaposi sarcoma 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 |