Phase I/II Trial of Arsenic Trioxide (As2O3) With Ascorbic Acid in the Treatment of Relapsed/Refractory Multiple Myeloma
OBJECTIVES:
- Determine the maximum tolerated dose of arsenic trioxide when administered with
ascorbic acid in patients with recurrent or refractory multiple myeloma.
- Determine the therapeutic efficacy of this treatment combination in these patients.
- Determine the expression of MDR and Bcl-xL genes and the intracellular levels of GSH in
these patients before and after this treatment regimen and assess whether these
measures have prognostic value.
OUTLINE: This is a multicenter, dose-escalation study of arsenic trioxide.
- Phase I: Patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over
5-10 minutes on days 1-5 weekly for 5 weeks. Treatment continues every 7 weeks for up
to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of arsenic trioxide until the maximum
tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of
3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive the MTD of arsenic trioxide with ascorbic acid as outlined
above.
Patients are followed monthly for up to 5 years.
PROJECTED ACCRUAL: A total of 31-43 patients (6-18 for phase I and 16-25 for phase II) will
be accrued for this study within 2.5 years.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease response as measured by M protein quantitation and the percentage of plasma cell infiltration in bone marrow biopsies after every course
No
Kelvin Lee, MD
Study Chair
University of Miami Sylvester Comprehensive Cancer Center
United States: Federal Government
EPROST-20000156
NCT00006021
June 2000
March 2007
Name | Location |
---|---|
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
Baptist-South Miami Regional Cancer Program | Miami, Florida 33176 |
Cedars Medical Center | Miami, Florida 33136 |
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center | Miami Beach, Florida 33140 |