Phase II Evaluation of Low-Dose Oral Etoposide for the Treatment of Relapsed or Progressed AIDS-Related Kaposi's Sarcoma After Systemic Chemotherapy
- Conditions
- Sarcoma, KaposiHIV Infections
- Registration Number
- NCT00000807
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Denver Dept of Health and Hosps
🇺🇸Denver, Colorado, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Albany Med College / Division of HIV Medicine A158
🇺🇸Albany, New York, United States
Mid - Hudson Care Ctr
🇺🇸Albany, New York, United States
Yale Univ / New Haven
🇺🇸New Haven, Connecticut, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
K Norris Cancer Hosp / Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Adirondack Med Ctr at Saranac Lake
🇺🇸Albany, New York, United States
Saint Clare's Hosp and Health Ctr
🇺🇸New York, 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