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

Completed · Phase 2

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000807

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

41

Expected to finish

2000-07-01

Last updated by the study team

2021-10-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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