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

July 9, 2013 updated by: Oncotherapeutics

Phase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma

RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs.

PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the time to progression in patients with relapsed or refractory multiple myeloma (MM) treated with melphalan, arsenic trioxide, and ascorbic acid.
  • Determine the response rate (combined complete response, partial response, and minimal response) in patients treated with this regimen.
  • Determine the safety and tolerability of this regimen in these patients.

Secondary

  • Determine the time to response and overall survival of patients treated with this regimen.
  • Determine the effects of this regimen on renal failure associated with MM in these patients.

OUTLINE: This is an open-label, non-randomized, multicenter study.

Patients receive oral melphalan once daily on days 1-4 of week 1 and arsenic trioxide (ATO) IV over 1-2 hours and ascorbic acid IV over 15 minutes on days 1-4 of week 1 and then twice weekly during weeks 2-5. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression any time after course 1 also receive oral prednisone once daily on days 1-4 and 22-25 of each course. Patients achieving a complete response after 6 courses of therapy undergo bone marrow biopsy and receive no further therapy. Patients achieving stable disease or a partial response after 6 courses of therapy continue to receive ATO and ascorbic acid once weekly.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Palo Verde Hematology Oncology
    • California
      • Bakersfield, California, United States, 93309-0633
        • Comprehensive Blood and Cancer Center
      • Campbell, California, United States, 95008
        • Southbay Oncology / Hematology Medical Group
      • Fountain Valley, California, United States, 92708
      • Fresno, California, United States, 93720
        • Hematology-Oncology Medical Group of Fresno, Incorporated
      • Orange, California, United States, 92868
        • Hematology Oncology Medical Group of Orange County, Incorporated
      • Redondo Beach, California, United States, 90277
        • Cancer Care Associates Medical Group - Redondo Beach
      • Santa Rosa, California, United States, 95405
        • Redwood Regional Oncology Center - Sotoyome
      • Soquel, California, United States, 95073
        • Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital
      • Vista, California, United States, 92083
        • San Diego Cancer Center - Vista
      • West Hollywood, California, United States, 90069
        • Oncotherapeutics
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Atlanta Cancer Care - Roswell
    • Louisiana
      • New Orleans, Louisiana, United States, 70112-2699
        • Tulane Cancer Center at Tulane University Hospital and Clinic
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders at Suburban Hospital
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of The University of Pennsylvania
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists - Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma meeting at least 1 of the following criteria:
  • Relapsed disease after a response to standard first-line chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone [VAD] OR melphalan and prednisone) or first-line high-dose chemotherapy
  • Refractory disease (failed to achieve at least stable disease) to most recent chemotherapy with or without systemic corticosteroids
  • Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of ≥ 1 g/dL AND/OR urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours
  • No non-secretory myeloma
  • No plasma cell leukemia

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • Platelet count ≥ 50,000/mm^3 (30,000/mm^3 if bone marrow is extensively infiltrated)
  • Hemoglobin ≥ 8.0 g/dL
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Pancytopenia secondary to multiple myeloma or hypersplenism allowed

Hepatic

  • AST and ALT ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN (unless clearly related to disease)
  • No known active hepatitis B or C infection

Renal

  • Calcium < 14 mg/dL

Cardiovascular

  • No evidence of acute ischemia or new conduction system abnormality by electrocardiogram
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart failure
  • No poorly controlled hypertension
  • No prolonged corrected QT interval (> 460 ms) with potassium > 4 mmol/L and magnesium ≥ 1.8 mmol/L

Other

  • No active infection
  • No POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • No diabetes mellitus
  • No other serious medical or psychiatric illness that would preclude study participation
  • No known allergic reaction attributable to compounds of similar chemical or biological composition to study drugs
  • No history of grand mal seizures
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy or antibody therapy

Chemotherapy

  • See Disease Characteristics
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

  • See Disease Characteristics
  • No other concurrent corticosteroids

Radiotherapy

  • More than 4 weeks since prior radiotherapy

Surgery

  • More than 4 weeks since prior major surgery

Other

  • No other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oncotherapeutics

Investigators

  • Study Chair: James R. Berenson, MD, Oncotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 10, 2004

First Submitted That Met QC Criteria

June 10, 2004

First Posted (Estimate)

June 11, 2004

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONCOTHER-MAC001
  • CDR0000368637 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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