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
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
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.
Trial Officials
Von Roenn JH
Study Chair
Paredes J
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
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
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