A Study of Chemotherapy Plus Azidothymidine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

NCT00000987 | Completed Phase 1

• 2 other identifiers: ACTG 07511049
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoma, Kaposi; HIV Infections

Keywords

Vincristine; Doxorubicin; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; Zidovudine; Bleomycin

Interventions

Bleomycin sulfate DRUG

Vincristine sulfate DRUG

Doxorubicin hydrochloride DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Medication for grades 1 and 2 oral toxicity. Antiemetic agents, except steroids, for gastrointestinal toxicity. Toxicity grades according to NIAID Recommendations for Grading of Acute and Subacute Toxic Effects (Adults).
• Patients must demonstrate any of the following clinical and laboratory findings:
• or more mucocutaneous lesions with or without lymphedema.
• Progressive Kaposi's sarcoma (KS) with 10 or more new lesions in the month prior to study entry or visceral involvement.
• Oral mucosal lesion(s) requiring therapy.
• Prior history of Pneumocystis carinii pneumonia (PCP) or Mycobacterium avium intracellulare.
• Patients with any of the following constitutional symptoms with no etiology established may be included:
• Temperature \> 38 degrees C and/or drenching night sweats for more than 1 month.
• Watery diarrhea (= or \> 3 stools/day) for 2 or more weeks.
• Weight loss \> 10 percent of normal. Patients with carcinoma in situ of the cervix or localized squamous or basal cell carcinoma of the skin may be included.
• Active alcohol or drug abuse sufficient to prevent adequate compliance with study therapy.

You may not qualify if:

• Co-existing Condition:
• Patients with the following conditions will be excluded:
• Peripheral sensory or motor neuropathy.
• Opportunistic infections requiring therapy.
• Significant pulmonary (exertional dyspnea with minimal exercise) or cardiac insufficiency (New York Heart Association, status \> 2).
• Serious neuropsychiatric illness which would prevent informed consent of intensive treatment.
• Concurrent Medication:
• Excluded:
• Any drugs causing anemia, neutropenia, or significant risk of nephrotoxicity. Patients with a history of other systemic malignancies or lymphomas, except carcinoma in situ of the cervix or localized squamous or basal cell carcinoma of the skin, will be excluded from the study.
• Prior Medication:
• Excluded:
• Systemic antineoplastic chemotherapy.
• Excluded within 30 days of study entry:
• Any other investigational therapy.
• Antiretroviral agents (zidovudine, ribavirin).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• Brambilla D, Coombs R, Bremer JW, Reichelderfer PS, Kalish L, Shapiro DE. The contributions of assay variation and biological variation to the variability of HIV RNA measurements in serially collected clinical specimens. Int Conf AIDS. 1998;12:805 (abstract no 42163)

  BACKGROUND

• Gill PS, Miles SA, Mitsuyasu RT, Montgomery T, McCarthy S, Espina BM, Feldstein M, Levine AM. Phase I AIDS Clinical Trials Group (075) study of adriamycin, bleomycin and vincristine chemotherapy with zidovudine in the treatment of AIDS-related Kaposi's sarcoma. AIDS. 1994 Dec;8(12):1695-9. doi: 10.1097/00002030-199412000-00009.

  PMID: 7534090 BACKGROUND

MeSH Terms

Conditions

Sarcoma, Kaposi; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Bleomycin; Vincristine; Doxorubicin; Zidovudine

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• PS Gill

  STUDY CHAIR

• S Miles

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: April 1, 1992
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (1)