A Phase I Study of Combination Chemotherapy (Adriamycin, Bleomycin, and Vincristine) and Azidothymidine in the Treatment of AIDS Related Kaposi's Sarcoma

Inclusion Criteria

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:

• 25 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.

Exclusion Criteria

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).
• Immunomodulating agents (steroids, interferons, naltrexone, isoprinosine, and interleukin-2).

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety