NCT00000807

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

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 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 until all 41 patients are enrolled. Patients continue therapy until maximal tumor response (either stable disease or complete response) is achieved or disease progression occurs.

Conditions

• Sarcoma, Kaposi
• HIV Infections

Interventions

Type	Name	Description
DRUG	Etoposide

Timeline

• Completion: 2000-07-01
• First posted: 2001-08-31
• Last updated: 2021-10-28

Locations

20 sites across 1 country: United States