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

This study has been terminated.
(Terminated early due to funding suspension by grant sponsor.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00227682
First received: September 26, 2005
Last updated: May 24, 2012
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Dietary Supplement: ascorbic acid
Drug: arsenic trioxide
Drug: dexamethasone
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability as measured by physical exams, blood tests, and adverse events reports weekly [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: June 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arsenic Trioxide
Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
Dietary Supplement: ascorbic acid Drug: arsenic trioxide Drug: dexamethasone Drug: thalidomide

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227682

Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Aleksandra Simic, MD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00227682     History of Changes
Other Study ID Numbers: CDR0000443708, OHSU-1277, OHSU-HEM-03100-L, P30CA069533
Study First Received: September 26, 2005
Last Updated: May 24, 2012
Health Authority: United States: Federal Government

Keywords provided by OHSU Knight Cancer Institute:
refractory multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Arsenic trioxide
Ascorbic Acid
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on November 20, 2014