Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Registration Number
- NCT00006021
- Lead Sponsor
- University of Miami
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug.
PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Disease response as measured by M protein quantitation and the percentage of plasma cell infiltration in bone marrow biopsies after every course
- Secondary Outcome Measures
Name Time Method Toxicity as measured by CTCAE criteria
Trial Locations
- Locations (4)
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Cedars Medical Center
🇺🇸Miami, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Baptist-South Miami Regional Cancer Program
🇺🇸Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center🇺🇸Miami Beach, Florida, United States