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Arsenic Trioxide, Thalidomide, Dexamethasone, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ascorbic acid
arsenic trioxide
dexamethasone
thalidomide
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arsenic Trioxide

Arm Description

Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety and tolerability as measured by physical exams, blood tests, and adverse events reports weekly

Full Information

First Posted
September 26, 2005
Last Updated
May 24, 2012
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00227682
Brief Title
Arsenic Trioxide, Thalidomide, Dexamethasone, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma
Official Title
A Phase II Study of Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
Terminated early due to funding suspension by grant sponsor.
Study Start Date
June 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Sometimes when chemotherapy is given, it does not stop the growth of cancer cells. The cancer is said to be resistant to chemotherapy. Giving arsenic trioxide together with chemotherapy may reduce drug resistance and allow the cancer cells to be killed. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
refractory multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arsenic Trioxide
Arm Type
Experimental
Arm Description
Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
Intervention Type
Dietary Supplement
Intervention Name(s)
ascorbic acid
Intervention Type
Drug
Intervention Name(s)
arsenic trioxide
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
thalidomide
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Safety and tolerability as measured by physical exams, blood tests, and adverse events reports weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandra Simic, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Arsenic Trioxide, Thalidomide, Dexamethasone, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma

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