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A Phase II Study of Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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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 InstitutePortland, Oregon  97239