Status:
TERMINATED
Arsenic Trioxide, Thalidomide, Dexamethasone, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, dexamethasone, and ascorbic acid, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping...
Detailed Description
OBJECTIVES: * 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...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma (MM)
- Relapsed or refractory disease
- Monoclonal immunoglobulin spike by serum electrophoresis of ≥ 1 gm/dL AND/OR urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours
- Has received ≥ 2 prior treatment regimens for MM
- None of the following are allowed:
- Non-secretory MM
- Plasma cell leukemia
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- ECOG 0-2
- Life expectancy
- More than 3 months
- Hematopoietic
- Platelet count ≥ 50,000/mm\^3 (30,000/mm\^3 if the bone marrow is extensively infiltrated)
- Hemoglobin ≥ 8.0 g/dL
- Absolute neutrophil count ≥ 1,000/mm\^3
- Hepatic
- AST and ALT \< 3.0 times upper limit of normal (ULN)
- Bilirubin \< 2.0 times ULN
- Renal
- Not specified
- Cardiovascular
- No cardiac disease, including any of the following conditions:
- History of recurrent supraventricular arrhythmia
- History of sustained ventricular tachycardia
- History of second or third degree AV block
- History of left bundle branch block
- Cardiomyopathy with LVEF \< 40%
- Uncontrolled ischemic heart disease
- No myocardial infarction within the past 6 months
- No prolonged QT interval \> 500 ms
- Other
- Not pregnant or nursing
- Negative pregnancy test
- No HIV positivity
- No neuropathy \> grade 3
- Potassium ≥ 4 mEq/L
- Magnesium ≥ 1.8 mg/dL
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- More than 30 days since prior investigational drugs
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00227682
Start Date
June 1 2004
End Date
February 1 2006
Last Update
May 28 2012
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098