A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma

Sponsor

Sequus Pharmaceuticals (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00002318

Collaborator

(none)

225

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.

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

Detailed Description

Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given on day 1 and every 2 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients must agree to have one or more representative KS lesions biopsied.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Adriamycin, Bleomycin, and Vincristine (ABV) in the Treatment of Severe AIDS-Related 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

Concurrent Medication:

Allowed:

Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.
Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
Foscarnet for new episodes of cytomegalovirus infection.
Colony-stimulating factors and erythropoietin.

Patients must have:

Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
At least 25 mucocutaneous lesions.
Ten or more new lesions in the prior month.
Documented visceral disease with at least two accessible cutaneous lesions.
Two accessible cutaneous lesions with edema.
Documented anti-HIV antibody.
No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).
Life expectancy > 4 months.

NOTE:

Patients who respond to therapy on this protocol, as well as those who fail the ABV combination, are eligible to enter the Liposome Technology open trial using DOX-SL alone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Clinically significant cardiac, hepatic, or renal disease.
Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss.
Inability to comply with the study.

Concurrent Medication:

Excluded:

Other cytotoxic chemotherapy.
Ganciclovir.

Patients with the following prior conditions are excluded:

Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function.
History of idiosyncratic or allergic reaction to bleomycin or vincristine.

Prior Medication:

Excluded:

Prior anthracycline therapy.
Cytotoxic chemotherapy or interferon treatment within the past 4 weeks.

Prior Treatment:

Excluded:

Radiation or electron beam therapy within the past 3 weeks.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Bay AIDS Ctr	Berkeley	California	United States	94705
2	Pacific Oaks Med Group	Beverly Hills	California	United States	90211
3	Hematology - Oncology Med Group of San Fernando Valley	Encino	California	United States	91436
4	Dr Becky Miller	Los Angeles	California	United States	90048
5	Apogee Med Group	San Diego	California	United States	92103
6	UCSF - San Francisco Gen Hosp	San Francisco	California	United States	94110
7	Kaiser Permanente Med Ctr	San Francisco	California	United States	94115
8	UCSF	San Francisco	California	United States	94117
9	San Francisco Veterans Administration Med Ctr	San Francisco	California	United States	94121
10	UCSF	San Francisco	California	United States	941430324
11	Pacific Oaks Med Group	Sherman Oaks	California	United States	91403
12	Dr Mahmoud Mustafa	Washington	District of Columbia	United States	20037
13	Univ of Miami School of Medicine	Miami	Florida	United States	33136
14	H Lee Moffit Cancer Ctr and Research Institute	Tampa	Florida	United States	33612
15	American Med Research Institute	Atlanta	Georgia	United States	30329
16	Infectious Disease Rsch Consortium of GA / SE Clin Resources	Atlanta	Georgia	United States	30345
17	Northwestern Med Faculty Foundation	Chicago	Illinois	United States	60611
18	Rush Presbyterian Med College	Chicago	Illinois	United States	60612
19	Illinois Masonic Med Ctr / The Cancer Ctr	Chicago	Illinois	United States	60657
20	Henry Ford Hosp	Detroit	Michigan	United States	48202
21	Washington Univ	St Louis	Missouri	United States	63108
22	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
23	Saint Vincent's Hosp and Med Ctr	New York	New York	United States	10011
24	New York Univ Med Ctr	New York	New York	United States	10016
25	Saint Luke's - Roosevelt Hosp Ctr	New York	New York	United States	10023
26	Graduate Hosp / Tuttleman Cancer Ctr	Philadelphia	Pennsylvania	United States	19146
27	Comprehensive Care Ctr	Dallas	Texas	United States	75235
28	Baylor College of Medicine	Houston	Texas	United States	77030