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Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma Clinical research trials and Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma health trials occur in a lot of of places throughout the United States of America. 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 does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma. Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma clinical trial. Human subjects frequently get the finest healthcare available for their Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma  Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma
Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): Sequus Pharmaceuticals ,
Synopsis: To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.
Details: Patients are randomized to receive either DOX-SL or the BV combination. Infusions are given on day 1 and every 3 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 who respond to therapy will be followed every 2 months for up to 1 year. 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. - Maintenance therapy for tuberculosis, fungal, and herpes infections. - Therapy for new episodes of tuberculosis, fungal, and herpes infection except with potentially myelotoxic chemotherapy. - Foscarnet for cytomegalovirus infection. - Erythropoietin. Patients must have: - Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following: - At least 15 mucocutaneous lesions. - Six or more new lesions in the prior month. - Documented visceral disease with at least five accessible cutaneous lesions. - Documented anti-HIV antibody. - No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if REQUIRING treatment with myelotoxic drugs). - Life expectancy > 4 months. NOTE: - Patients who fail the BV combination or who relapse 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 disease. - Confusion, disorientation, CNS symptoms, or peripheral neuropathy. Concurrent Medication: Excluded: - Other cytotoxic chemotherapy. - Colony-stimulating factors. - 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 anthracyclines, bleomycin, or vincristine. - History of major psychiatric illness. Prior Medication: Excluded: - Cytotoxic chemotherapy or interferon therapy within the past 4 weeks. - More than one prior cycle of bleomycin/vincristine at any time. Prior Treatment: Excluded: - Radiation or electron beam therapy within the past 3 weeks.
Total Enrollment: 220
Location and Contact Information:
Beth Israel Hosp
Boston, Massachusetts, 02215
United States
Virginia Mason Research Center / Clinical Trial Unit
Seattle, Washington, 98101
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Twelve Oaks Hosp
Houston, Texas, 77074
United States
Additional Information:
Study ID Numbers: 134B; LTI-30-11
Study Start Date:
Record last reviewed: January 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002105
Other Sarcoma, Kaposi Studies:
1. A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma
2. Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals
3. A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3
4. A Phase I Study of the Combination of Recombinant GM-CSF, AZT, and Chemotherapy (ABV) (Adriamycin, Bleomycin, Vincristine) in AIDS and Kaposi's Sarcoma
5. A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma
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Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma
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