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.

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.

Sponsors

Lead sponsor: Nexstar Pharmaceuticals

Source NIH AIDS Clinical Trials Information Service
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.

Overall Status Completed
Phase Phase 3
Study Type Interventional
Condition
Intervention

Intervention type: Drug

Intervention name: Daunorubicin (liposomal)

Intervention type: Drug

Intervention name: Bleomycin sulfate

Intervention type: Drug

Intervention name: Vincristine sulfate

Intervention type: Drug

Intervention name: Doxorubicin hydrochloride

Eligibility

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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
Univ of Arizona / Arizona Cancer Ctr | Tucson, Arizona, 85724, United States
Kenneth Norris Jr Cancer Hosp | Los Angeles, California, 90033, United States
Desert Hosp Comprehensive Cancer Ctr | Palm Springs, California, 92262, United States
Saint Francis Mem Hosp | San Francisco, California, 94109, United States
Davies Med Ctr | San Francisco, California, 94114, United States
Denver Gen Hosp | Denver, Colorado, 802044507, United States
George Washington Univ Med Ctr | Washington, District of Columbia, 20037, United States
Univ of Miami Dept of Medicine | Miami, Florida, 33136, United States
Northwestern Univ Med School | Chicago, Illinois, 60611, United States
New England Deaconess Hosp | Boston, Massachusetts, 02215, United States
New York Univ Med Ctr | New York, New York, 10016, United States
Kaiser Permanente Med Ctr | Portland, Oregon, 97227, United States
Dr Edward Stool | Houston, Texas, 77004, United States
Location Countries

United States

Verification Date

March 1996

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Primary purpose: Treatment

Source: ClinicalTrials.gov