Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS
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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.
Condition | Intervention | Phase |
---|---|---|
Sarcoma, Kaposi HIV Infections |
Drug: Doxorubicin hydrochloride (liposomal) Drug: Filgrastim Drug: Bleomycin sulfate Drug: Vincristine sulfate |
Phase 2 |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma |
Estimated Enrollment: | 120 |
Study Completion Date: | August 1998 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
United States, Alabama | |
Alabama Therapeutics CRS | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
UCLA CARE Center CRS | |
Los Angeles, California, United States, 90095 | |
USC CRS | |
Los Angeles, California, United States, 90033 | |
Ucsf Aids Crs | |
San Francisco, California, United States | |
United States, Colorado | |
University of Colorado Hospital CRS | |
Aurora, Colorado, United States, 80262 | |
United States, Florida | |
Univ. of Miami AIDS CRS | |
Miami, Florida, United States, 33136 | |
United States, Hawaii | |
Univ. of Hawaii at Manoa, Leahi Hosp. | |
Honolulu, Hawaii, United States, 96816 | |
Queens Med. Ctr. | |
Honolulu, Hawaii, United States, 96813 | |
United States, Illinois | |
Northwestern University CRS | |
Chicago, Illinois, United States, 60611 | |
Rush Univ. Med. Ctr. ACTG CRS | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Indiana Univ. School of Medicine, Infectious Disease Research Clinic | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
Beth Israel Deaconess - East Campus A0102 CRS | |
Boston, Massachusetts, United States, 02215 | |
Bmc Actg Crs | |
Boston, Massachusetts, United States, 02118 | |
Massachusetts General Hospital ACTG CRS | |
Boston, Massachusetts, United States | |
United States, Missouri | |
Washington U CRS | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
SUNY - Buffalo, Erie County Medical Ctr. | |
Buffalo, New York, United States, 14215 | |
Memorial Sloan-Kettering Cancer Ctr. | |
New York, New York, United States, 10021 |
Study Chair: | Mitsuyasu R | |
Study Chair: | Krown S | |
Study Chair: | Von Roenn JH |
Additional Information:
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001059 History of Changes |
Other Study ID Numbers: | ACTG 286, 11262 |
Study First Received: | November 2, 1999 |
Last Updated: | April 13, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vincristine Sarcoma, Kaposi Liposomes Doxorubicin Drug Therapy, Combination |
Granulocyte Colony-Stimulating Factor Acquired Immunodeficiency Syndrome Bleomycin Drug Carriers |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Sarcoma Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpesviridae Infections DNA Virus Infections |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue Bleomycin Doxorubicin Vincristine Lenograstim Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on February 21, 2013