Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sarcoma, Kaposi; HIV Infections
Intervention: Doxorubicin hydrochloride (liposomal) (Drug); Filgrastim (Drug); Bleomycin sulfate (Drug); Vincristine sulfate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Mitsuyasu R, Study Chair
Krown S, Study Chair
Von Roenn JH, Study Chair
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.
Clinical Details
Official title: Comparison Study of Liposomal Doxorubicin With or Without Bleomycin and Vincristine for the Treatment of Advanced AIDS-Associated Kaposi's Sarcoma
Study design: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
San Francisco Gen Hosp, San Francisco, California 941102859, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California 941102859, United States
UCLA CARE Ctr, Los Angeles, California 90095, United States
Univ of Southern California / LA County USC Med Ctr, Los Angeles, California 900331079, United States
Univ of Colorado Health Sciences Ctr, Denver, Colorado 80262, United States
Denver Dept of Health and Hosps, Denver, Colorado 80262, United States
Univ of Miami School of Medicine, Miami, Florida 331361013, United States
Univ of Hawaii, Honolulu, Hawaii 96816, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Illinois Masonic Med Ctr, Chicago, Illinois 606575147, United States
Indiana Univ Hosp, Indianapolis, Indiana 462025250, United States
Beth Israel Deaconess Med Ctr, Boston, Massachusetts 02215, United States
Boston Med Ctr, Boston, Massachusetts 02118, United States
Mem Sloan - Kettering Cancer Ctr, New York, New York 10021, United States
Mount Sinai Med Ctr, New York, New York 10029, United States
SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York 14215, United States
Mid - Hudson Care Ctr, Albany, New York 122083479, United States
Albany Med College / Division of HIV Medicine A158, Albany, New York 122083479, United States
Julio Arroyo, West Columbia, South Carolina 29169, United States
Additional Information
Click here for more information about Doxorubicin hydrochloride (liposomal)
Related publications: 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
Last updated: June 23, 2005
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