A Phase II Study of Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
- Determine the safety and side effects of arsenic trioxide administered in combination
with thalidomide, dexamethasone, and ascorbic acid in patients with relapsed or
refractory multiple myeloma.
- Determine, preliminarily, the anticancer effects of this regimen in these patients.
- Determine the duration of anticancer effects in patients treated with this regimen.
- Determine the effect of this regimen on bone and immune function in these patients.
OUTLINE: Patients receive arsenic trioxide IV continuously and oral ascorbic acid once daily
on days 1-5 in week 1 and twice weekly in weeks 2-12 and oral thalidomide once daily in
weeks 1-14. Treatment with arsenic trioxide, ascorbic acid, and thalidomide repeats every 14
weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients also receive oral dexamethasone once daily on days 1-4. Treatment with
dexamethasone repeats every 28 days.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response, partial response, and minimal response) as measured by bone marrow aspirate, biopsy, cytogenetic analysis, serum, urine, and immunofixation skeletal survey at 6 months and end of study treatment
Aleksandra Simic, MD
OHSU Knight Cancer Institute
United States: Federal Government
|OHSU Knight Cancer Institute||Portland, Oregon 97239|