HIV Infections Clinical Trial
Official title:
Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy
NCT number | NCT00000807 |
Other study ID # | ACTG 269 |
Secondary ID | 11245 |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Est. completion date | July 2000 |
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | July 2000 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Adirondack Med Ctr at Saranac Lake | Albany | New York |
United States | Albany Med College / Division of HIV Medicine A158 | Albany | New York |
United States | Mid - Hudson Care Ctr | Albany | New York |
United States | Univ of Alabama at Birmingham | Birmingham | Alabama |
United States | Boston Med Ctr | Boston | Massachusetts |
United States | SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York |
United States | Northwestern Univ Med School | Chicago | Illinois |
United States | Denver Dept of Health and Hosps | Denver | Colorado |
United States | Univ of Colorado Health Sciences Ctr | Denver | Colorado |
United States | City Hosp Ctr at Elmhurst / Mount Sinai Hosp | Elmhurst | New York |
United States | Indiana Univ Hosp | Indianapolis | Indiana |
United States | K Norris Cancer Hosp / Los Angeles County - USC Med Ctr | Los Angeles | California |
United States | Univ of Southern California / LA County USC Med Ctr | Los Angeles | California |
United States | Univ of Miami School of Medicine | Miami | Florida |
United States | Yale Univ / New Haven | New Haven | Connecticut |
United States | Columbia Presbyterian Med Ctr | New York | New York |
United States | Mount Sinai Med Ctr | New York | New York |
United States | Saint Clare's Hosp and Health Ctr | New York | New York |
United States | San Francisco Gen Hosp | San Francisco | California |
United States | Julio Arroyo | West Columbia | South Carolina |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Bristol-Myers Squibb |
United States,
Evans SR, Krown SE, Testa MA, Cooley TP, Von Roenn JH. Phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressive AIDS-related Kaposi's sarcoma: an AIDS Clinical Trials Group clinical study. J Clin Oncol. 2002 Aug 1;20(15):3236-41. — View Citation
Mans D, Sprinz E, Sander I, Kalakun F, Jung G, Prolla G, Schwartsmann G. A phase II study of oral etoposide (VP-16) in AIDS-related Kaposi's sarcoma (KS). Int Conf AIDS. 1994 Aug 7-12;10(1):173 (abstract no PB0118)
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