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Comparison of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Comparison of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Comparison of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS Clinical research trials and Comparison of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 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 of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Comparison of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS clinical trial. Participants oftentimes recieve the most expert healthcare available for their Comparison of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > 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 of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS
Comparison of Liposomal Doxorubicin Used Alone or in Combination with Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients with AIDS
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Sequus Pharmaceuticals,Amgen
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
MitsuyasuR, Study Chair,
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Mid - Hudson Care Ctr
Albany, New York, 122083479
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Illinois Masonic Med Ctr
Chicago, Illinois, 606575147
United States
Denver Dept of Health and Hosps
Denver, Colorado, 80262
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Additional Information:
Study ID Numbers: ACTG 286;
Study Start Date:
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001059
Other Hiv Infections Studies:
1. A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients with Recurrent Thrush
2. Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
3. A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS
4. A Study of Stem Cells and Filgrastim
5. Safety and Effectiveness of Fenofibrate and Pravastatin in HIV-Positive Patients with Abnormal Blood Lipids
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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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