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A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma Clinical research trials and A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma. A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma clinical trial. Human subjects often get the best healthcare available for their A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma  A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): Sequus Pharmaceuticals ,
Synopsis: To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated.
Details: Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.
Eligibility:
Study Type: Interventional, Treatment, Open Label, 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 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 infections except with potentially myelotoxic chemotherapy. - Foscarnet or ganciclovir for CMV infection. - Colony stimulating factors and erythropoietin. Patients must have: - Moderate to severe AIDS-related Kaposi's sarcoma. - Documented anti-HIV antibody. - No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs). NOTE: - Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Clinically significant cardiac disease. - Confusion or disorientation. Concurrent Medication: Excluded: - Other cytotoxic cancer chemotherapy. Patients with the following prior conditions are excluded: - Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function. - History of idiosyncratic or allergic reaction to anthracyclines. - History of major psychiatric illness. Prior Medication: Excluded within the past 4 weeks: - Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol). - Interferon treatment. Prior Treatment: Excluded within the past 3 weeks: - Radiation or electron beam therapy.
Total Enrollment:
Location and Contact Information:
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Dr Becky Miller
Los Angeles, California, 90048
United States
Rush Presbyterian Med College
Chicago, Illinois, 60612
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Northwestern Med Faculty Foundation
Chicago, Illinois, 60611
United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
United States
Pacific Oaks Med Group
Beverly Hills, California, 90211
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
United States
Comprehensive Care Ctr
Dallas, Texas, 75235
United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
New York Univ Med Ctr
New York City, New York, 10016
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10023
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Pacific Oaks Med Group
Sherman Oaks, California, 91403
United States
Illinois Masonic Med Ctr / The Cancer Ctr
Chicago, Illinois, 60657
United States
UCSF
San Francisco, California, 941430324
United States
American Med Research Institute
Atlanta, Georgia, 30329
United States
Virginia Mason Research Center / Clinical Trial Unit
Seattle, Washington, 98101
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Dr Mahmoud Mustafa
Washington D.C., District of Columbia, 20037
United States
Graduate Hosp / Tuttleman Cancer Ctr
Philadelphia, Pennsylvania, 19146
United States
Washington Univ
St. Louis, Missouri, 63108
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Infectious Disease Rsch Consortium of GA / SE Clin Resources
Atlanta, Georgia, 30345
United States
H Lee Moffit Cancer Ctr and Research Institute
Tampa, Florida, 33612
United States
UCSF
San Francisco, California, 94117
United States
Hematology - Oncology Med Group of San Fernando Valley
Encino, California, 91436
United States
Apogee Med Group
San Diego, California, 92103
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Twelve Oaks Hosp
Houston, Texas, 77074
United States
Houston Immunological Institute
Houston, Texas, 77054
United States
Saint Vincent's Hosp and Med Ctr
New York City, New York, 10011
United States
Additional Information:
Study ID Numbers: 134C; LTI-30-12
Study Start Date:
Record last reviewed: January 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002319
Other Hiv Infections Studies:
1. Valganciclovir in Patients with CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
2. The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection
3. Evaluation of the Changes in HIV-1 Burden in Peripheral Blood and Lymphoid Tissue Following Zidovudine ( AZT ) Treatment in HIV-1-Infected Patients With CD4+ Cells Between 100 and 500 Cells/mm3.
4. Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients
5. A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects
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A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
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