Status:
COMPLETED
Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Sarcoma, Kaposi
HIV Infections
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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 sarco...
Detailed 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...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
July 1 2000
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00000807
End Date
July 1 2000
Last Update
October 28 2021
Active Locations (20)
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1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 900331079
3
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
4
San Francisco Gen Hosp
San Francisco, California, United States, 941102859