Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS
Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma
2 other identifiers
interventional
120
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
August 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedApril 17, 2012
April 1, 2012
November 2, 1999
April 13, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Sequus Pharmaceuticalscollaborator
- Amgencollaborator
Study Sites (17)
Alabama Therapeutics CRS
Birmingham, Alabama, 35294, United States
USC CRS
Los Angeles, California, 90033, United States
UCLA CARE Center CRS
Los Angeles, California, 90095, United States
Ucsf Aids Crs
San Francisco, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80262, United States
Univ. of Miami AIDS CRS
Miami, Florida, 33136, United States
Queens Med. Ctr.
Honolulu, Hawaii, 96813, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Bmc Actg Crs
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, 02215, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Washington U CRS
St Louis, Missouri, 63110, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215, United States
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, 10021, United States
Related Publications (1)
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
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mitsuyasu R
- STUDY CHAIR
Krown S
- STUDY CHAIR
Von Roenn JH
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
August 1, 1998
Last Updated
April 17, 2012
Record last verified: 2012-04