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Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy Clinical research trials and Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy. Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy clinical trial. Participants frequently get the best healthcare available for their Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy  Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy
Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy
For Condition: Sarcoma, Kaposi,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb
Synopsis: To assess the toxicity, tumor response rate, and effect on quality of life of daily low-dose etoposide administered for 7 consecutive days every other week in patients with AIDS-related Kaposi's sarcoma that has relapsed or progressed after systemic chemotherapy. Etoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time.
Details: Etoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time. Patients receive low-dose oral etoposide on days 1 through 7 of every 2-week cycle. Patients who achieve a complete or partial response after two cycles and have no toxicity greater than grade 2 may have their dose escalated for subsequent cycles. If there are no responses to therapy among the first 14 evaluable patients, the study will close; if there is at least one objective response to therapy among the first 14 evaluable patients, enrollment will continue until all 41 patients are enrolled. Patients continue therapy until maximal tumor response (either stable disease or complete response) is achieved or disease progression occurs.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Maintenance therapy for opportunistic infections. Patients must have: - HIV infection. - Kaposi's sarcoma that has relapsed or progressed. - Mucocutaneous lesions (15 or more) and/or symptomatic mucosal lesions and/or visceral Kaposi's sarcoma (symptomatic lymphedema qualifies patients in the absence of these three conditions). - NO active acute opportunistic infections requiring treatment with myelosuppressive antibiotics (maintenance for OIs is permitted). - Consent of parent or guardian if less than 18 years of age. NOTE: - This study is approved for prisoner participation. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Other active malignancies except basal cell carcinoma of the skin, or carcinoma in situ of the cervix. - Grade 3 or worse peripheral neuropathy. - Altered mental status that would prevent informed consent or prevent study compliance. Patients with the following prior condition are excluded: Neuropsychiatric history. Prior Medication: Excluded: - Prior etoposide. - Any other anti-KS drugs within 14 days prior to study entry. - Any investigational drug other than antiretrovirals within 14 days prior to study entry. - Any prior investigational agent, if given as the ONLY prior treatment for KS. Prior Treatment: Excluded: - Radiation therapy within 7 days prior to study entry. Continued alcohol consumption or continued intravenous drug use that would impair ability to comply with study requirements.
Total Enrollment: 41
Location and Contact Information:
Overall Study Official:
VonJH, Study Chair,
Denver Dept of Health and Hosps
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
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Saint Clare's Hosp and Health Ctr
New York City, New York, 10019
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Adirondack Med Ctr at Saranac Lake
Albany, New York, 122083479
United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
United States
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr
Los Angeles, California, 900331079
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Additional Information:
Study ID Numbers: ACTG 269;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000807
Other Hiv Infections Studies:
1. A Study of the Safety and Effectiveness of an HIV Vaccine for HIV-Positive Patients Receiving Anti-HIV Drugs for at Least 2 Years
2. A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy
3. Problems Associated with the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women
4. Rifabutin Therapy for the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
5. Safety and Effectiveness of Anti-HIV Vaccines in HIV-Negative Adults
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Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy
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