A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.

Nexstar Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Sarcoma, Kaposi; HIV Infections

Treatments: Drug: Bleomycin sulfate; Drug: Doxorubicin hydrochloride; Drug: Vincristine sulfate; Drug: Daunorubicin (liposomal)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002093

103-09

121A

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).