A Phase II Study of Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
A Phase II Study of Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
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 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Aleksandra Simic, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000443708
NCT ID:
NCT00227682
Start Date:
June 2004
Completion Date:
February 2006
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- refractory multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| OHSU Knight Cancer Institute | Portland, Oregon 97239 |
