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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00002318
Other study ID # 134A
Secondary ID LTI-30-10
Status Active, not recruiting
Phase Phase 3
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date January 1996
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 225
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Doxorubicin hydrochloride (liposomal)

Bleomycin sulfate

Vincristine sulfate

Doxorubicin hydrochloride


Locations

Country Name City State
United States American Med Research Institute Atlanta Georgia
United States Infectious Disease Rsch Consortium of GA / SE Clin Resources Atlanta Georgia
United States East Bay AIDS Ctr Berkeley California
United States Pacific Oaks Med Group Beverly Hills California
United States Roswell Park Cancer Institute Buffalo New York
United States Illinois Masonic Med Ctr / The Cancer Ctr Chicago Illinois
United States Northwestern Med Faculty Foundation Chicago Illinois
United States Rush Presbyterian Med College Chicago Illinois
United States Comprehensive Care Ctr Dallas Texas
United States Henry Ford Hosp Detroit Michigan
United States Hematology - Oncology Med Group of San Fernando Valley Encino California
United States Baylor College of Medicine Houston Texas
United States Dr Becky Miller Los Angeles California
United States Univ of Miami School of Medicine Miami Florida
United States New York Univ Med Ctr New York New York
United States Saint Luke's - Roosevelt Hosp Ctr New York New York
United States Saint Vincent's Hosp and Med Ctr New York New York
United States Graduate Hosp / Tuttleman Cancer Ctr Philadelphia Pennsylvania
United States Apogee Med Group San Diego California
United States Kaiser Permanente Med Ctr San Francisco California
United States San Francisco Veterans Administration Med Ctr San Francisco California
United States UCSF San Francisco California
United States UCSF San Francisco California
United States UCSF - San Francisco Gen Hosp San Francisco California
United States Pacific Oaks Med Group Sherman Oaks California
United States Washington Univ St Louis Missouri
United States H Lee Moffit Cancer Ctr and Research Institute Tampa Florida
United States Dr Mahmoud Mustafa Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Sequus Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gill PS, Wernz J, Scadden DT, Cohen P, Mukwaya GM, von Roenn JH, Jacobs M, Kempin S, Silverberg I, Gonzales G, Rarick MU, Myers AM, Shepherd F, Sawka C, Pike MC, Ross ME. Randomized phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. J Clin Oncol. 1996 Aug;14(8):2353-64. — View Citation

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