Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS

NCT ID: NCT00001059

Last Updated: 2012-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1998-08-31

Brief Summary

To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life.

Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.

Detailed Description

Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.

Patients are randomized to receive intravenous DOX-SL alone or in combination with vincristine/bleomycin every 2 weeks. Filgrastim ( granulocyte colony-stimulating factor; G-CSF ) may be given as needed for neutropenia.

AS PER AMENDMENT 11/7/96: Based on interim review data, it is recommended that subjects receiving DOX-SL plus vincristine/bleomycin have vincristine/bleomycin discontinued and receive DOX-SL alone unless, in the opinion of the treating physician, they are benefitting from the DOX-SL plus vincristine/bleomycin regimen.

Conditions

Sarcoma, Kaposi; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Doxorubicin hydrochloride (liposomal)

Intervention Type: DRUG

Filgrastim

Intervention Type: DRUG

Bleomycin sulfate

Intervention Type: DRUG

Vincristine sulfate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• G-CSF.
• Licensed or Treatment IND-approved antiretrovirals ( AZT, ddI, ddC, d4T ).
• PCP prophylaxis (required if CD4 count < 200 cells/mm3).
• Chemoprophylaxis or maintenance for bacterial infections, candidiasis, MAC, and herpes simplex.
• Up to 14 days of metronidazole.
• Recombinant erythropoietin.

Patients must have:

• Documented HIV infection.
• Advanced stage Kaposi's sarcoma.
• No active acute opportunistic infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Significant pulmonary insufficiency (unless due to pulmonary KS).
• Significant cardiac insufficiency.
• Other active malignancies except for basal or squamous cell carcinoma of the skin or in situ cervical cancer.
• Grade 2 or worse peripheral neuropathy.
• Altered mental status that prevents informed consent.
• Active Mycobacterium tuberculosis.
• Hypersensitivity or allergic reaction to any study drugs or E. coli-derived medications such as filgrastim (G-CSF).

Concurrent Medication:

Excluded:

• GM-CSF.
• Drugs associated with peripheral neuropathy (other than approved antiretrovirals and vincristine).
• Multi-drug therapy for active Mycobacterium tuberculosis (although isoniazid and pyridoxine is allowed as treatment for a positive PPD, with permission of study chair).

Concurrent Treatment:

Excluded:

• Radiation therapy to study marker lesions.

Patients with the following prior condition are excluded:

• Neuropsychiatric history.

Prior Medication:

Excluded:

• Any anti-KS therapy within 21 days prior to study entry.
• Prior systemic therapy with any anthracycline (including liposomal anthracyclines), vincristine, or bleomycin.
• Any investigational drug (other than those available through Treatment IND and used for FDA-sanctioned purposes) within 14 days prior to study entry.

PER AMENDMENT 11/29/95:

• No more than 2 cycles of any systemic chemotherapy for Kaposi's sarcoma.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sequus Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Amgen

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitsuyasu R

Role: STUDY_CHAIR

Krown S

Role: STUDY_CHAIR

Von Roenn JH

Role: STUDY_CHAIR

Locations

Alabama Therapeutics CRS

Birmingham, Alabama, United States

USC CRS

Los Angeles, California, United States

UCLA CARE Center CRS

Los Angeles, California, United States

Ucsf Aids Crs

San Francisco, California, United States

University of Colorado Hospital CRS

Aurora, Colorado, United States

Univ. of Miami AIDS CRS

Miami, Florida, United States

Queens Med. Ctr.

Honolulu, Hawaii, United States

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, United States

Northwestern University CRS

Chicago, Illinois, United States

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, United States

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, United States

Bmc Actg Crs

Boston, Massachusetts, United States

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, United States

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, United States

Washington U CRS

St Louis, Missouri, United States

SUNY - Buffalo, Erie County Medical Ctr.

Buffalo, New York, United States

Memorial Sloan-Kettering Cancer Ctr.

New York, New York, United States

Countries

United States

References

Mitsuyasu R, et al. Comparison study of liposomal doxorubicin (DOX) alone or with bleomycin and vincristine (DBV) for treatment of advanced AIDS-associated Kaposi's sarcoma (AIDS-KS): AIDS Clinical Trial Group (ACTG) protocol 286 (meeting abstract). Proc Annu Meet Am Soc Clin Oncol. 1997;16:A191

Reference Type: BACKGROUND

Other Identifiers

11262

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 286

Identifier Type: -

Identifier Source: org_study_id