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.

Sponsor

Nexstar Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00002093

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma, Kaposi HIV Infections	Drug: Daunorubicin (liposomal) Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

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.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Arizona / Arizona Cancer Ctr	Tucson	Arizona	United States	85724
2	Kenneth Norris Jr Cancer Hosp	Los Angeles	California	United States	90033
3	Desert Hosp Comprehensive Cancer Ctr	Palm Springs	California	United States	92262
4	Saint Francis Mem Hosp	San Francisco	California	United States	94109
5	Davies Med Ctr	San Francisco	California	United States	94114
6	Denver Gen Hosp	Denver	Colorado	United States	802044507
7	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
8	Univ of Miami Dept of Medicine	Miami	Florida	United States	33136
9	Northwestern Univ Med School	Chicago	Illinois	United States	60611
10	New England Deaconess Hosp	Boston	Massachusetts	United States	02215
11	New York Univ Med Ctr	New York	New York	United States	10016
12	Kaiser Permanente Med Ctr	Portland	Oregon	United States	97227
13	Dr Edward Stool	Houston	Texas	United States	77004