A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following symptoms or conditions are excluded:
• •Opportunistic infection requiring treatment with myelosuppressive antibiotics (unless on G-CSF or GM-CSF).
• •Other active malignancies except basal cell carcinoma of the skin or in situ cervical carcinoma.
• •Prior history or current clinical evidence of peripheral neuropathy (= or \> grade 1), pancreatitis, intractable diarrhea, or active seizure disorder not controlled by antiseizure medication.
• •Significant pulmonary insufficiency (exertional dyspnea with minimal exertion, except that due to pulmonary Kaposi's sarcoma) or cardiac insufficiency (New York Heart Association status \> 2).
• •Neuropsychiatric history or altered mental status that would prevent informed consent or that would not permit compliance with this protocol.
• •Concurrent Medication:
• •Excluded:
• •Myelosuppressive antibiotics (unless on G-CSF or GM-CSF).
• •Investigational agents other than drugs available on treatment IND and used for FDA sanctioned indications, or other antiviral, immunomodulating or antitumor drugs.
• •Drugs associated with peripheral neuropathy (other than ddI, ddC, or vincristine), including hydralazine, disulfiram, nitrofurantoin, cisplatin, diethyldithiocarbamate, gold, rifampin, chloramphenicol, clioquinol, ethambutol, ethionamide, glutethimide, sodium cyanate, and thalidomide.
• •Patients with the following prior conditions or symptoms are excluded:
• •Neuropsychiatric history or altered mental status that would prevent informed consent or that would not permit compliance with this protocol.
• •Prior Medication:
• •Excluded:
• •Systemic treatment with doxorubicin, bleomycin, or vincristine.
• •Antitumor (Kaposi's sarcoma) drugs within 7 days of study entry.
• •Any investigational drug (other than drugs available on treatment IND and used for FDA sanctioned indications) within 14 days of study entry.
• •Neurotoxic drugs (other than ddI or ddC) within 30 days of study entry.
• •Intralesional injections to a Kaposi's sarcoma marker lesion within 30 days of study entry.
• •Prior Treatment:
• •Excluded:
• •Irradiation of a Kaposi's sarcoma marker lesion within 30 days of study entry.
• •Alcohol consumption is strongly discouraged.