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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

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

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Etoposide


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (2)

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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