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A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma Clinical research trials and A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma. A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma clinical trial. Subjects often receive the most expert healthcare possible for their A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma  A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
For Condition: Sarcoma, Kaposi,HIV Infections
Status: No longer recruiting
Sponsor(s): Sequus Pharmaceuticals ,
Synopsis: To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.
Details: Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given on day 1 and every 2 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients must agree to have one or more representative KS lesions biopsied.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month. - Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy. - Foscarnet for new episodes of cytomegalovirus infection. - Colony-stimulating factors and erythropoietin. Patients must have: - Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following: - At least 25 mucocutaneous lesions. - Ten or more new lesions in the prior month. - Documented visceral disease with at least two accessible cutaneous lesions. - Two accessible cutaneous lesions with edema. - Documented anti-HIV antibody. - No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs). - Life expectancy > 4 months. NOTE: - Patients who respond to therapy on this protocol, as well as those who fail the ABV combination, are eligible to enter the Liposome Technology open trial using DOX-SL alone. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Clinically significant cardiac, hepatic, or renal disease. - Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss. - Inability to comply with the study. Concurrent Medication: Excluded: - Other cytotoxic chemotherapy. - Ganciclovir. Patients with the following prior conditions are excluded: - Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function. - History of idiosyncratic or allergic reaction to bleomycin or vincristine. Prior Medication: Excluded: - Prior anthracycline therapy. - Cytotoxic chemotherapy or interferon treatment within the past 4 weeks. Prior Treatment: Excluded: - Radiation or electron beam therapy within the past 3 weeks.
Total Enrollment: 225
Location and Contact Information:
Baylor College of Medicine
Houston, Texas, 77030
United States
Illinois Masonic Med Ctr / The Cancer Ctr
Chicago, Illinois, 60657
United States
Rush Presbyterian Med College
Chicago, Illinois, 60612
United States
UCSF
San Francisco, California, 94117
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
UCSF
San Francisco, California, 941430324
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
H Lee Moffit Cancer Ctr and Research Institute
Tampa, Florida, 33612
United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Washington Univ
St. Louis, Missouri, 63108
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10023
United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
United States
New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Infectious Disease Rsch Consortium of GA / SE Clin Resources
Atlanta, Georgia, 30345
United States
Dr Mahmoud Mustafa
Washington D.C., District of Columbia, 20037
United States
Graduate Hosp / Tuttleman Cancer Ctr
Philadelphia, Pennsylvania, 19146
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
United States
Dr Becky Miller
Los Angeles, California, 90048
United States
Saint Vincent's Hosp and Med Ctr
New York City, New York, 10011
United States
Apogee Med Group
San Diego, California, 92103
United States
Pacific Oaks Med Group
Beverly Hills, California, 90211
United States
Comprehensive Care Ctr
Dallas, Texas, 75235
United States
Pacific Oaks Med Group
Sherman Oaks, California, 91403
United States
Northwestern Med Faculty Foundation
Chicago, Illinois, 60611
United States
American Med Research Institute
Atlanta, Georgia, 30329
United States
Hematology - Oncology Med Group of San Fernando Valley
Encino, California, 91436
United States
Additional Information:
Study ID Numbers: 134A; LTI-30-10
Study Start Date:
Record last reviewed: January 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002318
Other Hiv Infections Studies:
1. A Phase I Study of AZT and Human Interferon Alpha (Recombinant Alpha-2A and Lymphoblastoid) in the Treatment of AIDS-Associated Kaposi's Sarcoma
2. Safety and Effectiveness of an Experimental Drug, IM862, in Treating Kaposi's Sarcoma in AIDS Patients
3. A Safety/Efficacy Study of SGN-30 (Antibody) in Patients with Refractory or Recurrent CD30+ Hematologic Malignancies
4. Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals
5. A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
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