HIV Infections, Sarcoma, Kaposi
Conditions
Keywords
Vincristine, Sarcoma, Kaposi, Liposomes, Doxorubicin, Acquired Immunodeficiency Syndrome, Bleomycin, Daunorubicin, Drug Carriers
Brief summary
To compare the toxicity profiles (severity and time to onset from initiation of therapy) between daunorubicin (liposomal) and combination chemotherapy with doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with antiretroviral therapy. To compare the duration of responses, response rates, and times to response.
Interventions
DRUGDaunorubicin (liposomal)
DRUGBleomycin sulfate
DRUGVincristine sulfate
DRUGDoxorubicin hydrochloride
Sponsors
Nexstar Pharmaceuticals
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must have: * HIV infection. * Advanced Kaposi's sarcoma. Prior Medication: Allowed: * Prior intralesional vinblastine.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Acute intercurrent infection other than genital herpes. * Uncompensated cardiovascular, hepatic, renal, or pulmonary disease unrelated to Kaposi's sarcoma. * Symptomatic peripheral neuropathy. * Any condition that compromises ability to give informed consent or complete the study. Concurrent Medication: Excluded: * Concurrent ganciclovir. Patients with the following prior conditions are excluded: * Symptomatic AIDS-defining opportunistic infection within 2 weeks of entry. * History of malignancy other than Kaposi's sarcoma, basal cell carcinoma, or carcinoma in situ of the cervix. Prior Medication: Excluded: * Prior systemic chemotherapy. * Intralesional therapies within 7 days prior to study entry. * Growth factors (G-CSF or GM-CSF), immune modifiers, or investigational agents within 14 days prior to study entry. * Interferon preparations (alpha or beta) within 28 days prior to study entry. Prior Treatment: Excluded within 7 days prior to study entry: * Radiation. * Local therapies (e.g., cryotherapy).
Countries
United States
Outcome results
None listed