Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy
NCT ID: NCT00000807
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2000-07-31
Brief Summary
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Etoposide may be at least as, or even more, effective and less myelotoxic when given in low doses over prolonged periods of time.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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Etoposide
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Von Roenn JH
Role: STUDY_CHAIR
Paredes J
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, 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
San Francisco Gen Hosp
San Francisco, California, United States
Denver Dept of Health and Hosps
Denver, Colorado, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Yale Univ / New Haven
New Haven, Connecticut, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Boston Med Ctr
Boston, Massachusetts, 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
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, United States
Saint Clare's Hosp and Health Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Julio Arroyo
West Columbia, South Carolina, United States
Countries
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References
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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)
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. doi: 10.1200/JCO.2002.12.038.
Other Identifiers
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11245
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 269
Identifier Type: -
Identifier Source: org_study_id