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

• Status: Completed
• Trial end date: 2000-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Bristol-Myers Squibb
• Treatments: Etoposide; Etoposide phosphate

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.