Search / Trial NCT00000807

Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of September 11, 2024

Completed

Keywords

Sarcoma, Kaposi Etoposide Acquired Immunodeficiency Syndrome

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 u...

Gender

ALL

Eligibility 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.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Birmingham, Alabama, United States

Los Angeles, California, United States

Indianapolis, Indiana, United States

New York, New York, United States

West Columbia, South Carolina, United States

San Francisco, California, United States

Chicago, Illinois, United States

New York, New York, United States

New Haven, Connecticut, United States

Miami, Florida, United States

Albany, New York, United States

Albany, New York, United States

Albany, New York, United States

Buffalo, New York, United States

Elmhurst, New York, United States

New York, New York, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

Denver, Colorado, United States

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0