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

This study is currently recruiting patients.

Sponsored by: Oncotherapeutics
Information provided by: National Cancer Institute (NCI)

Purpose

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 IV trial is continuing to study the side effects of giving melphalan together with arsenic trioxide and ascorbic acid after it has been approved for use in treating patients with relapsed or refractory multiple myeloma.

Condition Treatment or Intervention Phase
stage II multiple myeloma
stage III multiple myeloma
refractory plasma cell neoplasm
 Drug: arsenic trioxide
 Drug: ascorbic acid
 Drug: melphalan
 Procedure: chemosensitization/potentiation
 Procedure: chemotherapy
Phase IV

MedlinePlus related topics:  Immune System and Disorders;   Lymphatic Diseases;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase IV Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma

Further Study Details: 

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 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 100 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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

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


Location and Contact Information


Arizona
      Palo Verde Hematology-Oncology, Glendale,  Arizona,  85304,  United States; Recruiting
Joseph Raymond Volk, MD  602-978-6255    jvolk@pvhomed.com 

California
      Cancer Care Associates Medical Group - Redondo Beach, Redondo Beach,  California,  90277,  United States; Recruiting
Syed M. Jilani, MD  310-750-3300 

      Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital, Soquel,  California,  95073,  United States; Recruiting
J. Talisman Pomeroy, MD  831-462-8750    drtal@cybercancer.com 

      Comprehensive Blood and Cancer Center, Bakersfield,  California,  93309-0633,  United States; Recruiting
Ravindranath Patel, MD  661-322-2206 

      Hematology-Oncology Medical Group of Fresno, Incorporated, Fresno,  California,  93720,  United States; Recruiting
Marshall S. Flam, MD, FACP  209-447-4949    mflam@pacbell.net 

      Fountain Valley,  California,  92708,  United States; Recruiting
Robert A. Moss, MD  714-641-1128 

      Oncotherapeutics, West Hollywood,  California,  90069,  United States; Recruiting
James R. Berenson, MD  310-623-1200    obanuclos@oncotherapeutics-us.com 

      Redwood Regional Oncology Center - Sotoyome, Santa Rosa,  California,  95405,  United States; Recruiting
Marek J. Bozdech, MD  707-525-4080    mbozdech@rrmginc.com 

      San Diego Cancer Center - Vista, Encinitas,  California,  92024,  United States; Recruiting
Alberto Bessudo, MD  760-634-6661 

      Southbay Oncology / Hematology Medical Group, Campbell,  California,  95008,  United States; Recruiting
Steven Scates, MD  408-376-2300    scates@garlic.com 

Florida
      Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States; Recruiting
Jose Lutzky, MD  305-535-3305 

Georgia
      Atlanta Cancer Care - Roswell, Roswell,  Georgia,  30076,  United States; Recruiting
Ronald G. Steis, MD  770-740-9664 

Louisiana
      Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans,  Louisiana,  70112,  United States; Recruiting
Hana Safah, MD  504-988-6070    hsafah@tulane.edu 

Maryland
      Center for Cancer and Blood Disorders, Bethesda,  Maryland,  20817,  United States; Recruiting
Ralph Vincent Boccia, MD, FACP  301-571-0019 

Michigan
      William Beaumont Hospital - Royal Oak, Royal Oak,  Michigan,  48073,  United States; Recruiting
Ishmael A. Jaiyesimi, MD  248-551-6900    jamin@dnamil.com 

New Jersey
      Cancer Center at Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States; Recruiting
David Samuel Siegel, MD, PhD  201-996-5900    dsiegel@humed.com 

New York
      SUNY Downstate Medical Center, Brooklyn,  New York,  11203,  United States; Recruiting
Olcay Batuman, MD  718-270-2785    obatuman@downstate.edu 

Pennsylvania
      Abramson Cancer Center of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
Edward Allen Stadtmauer, MD  215-662-7910    edward.stadtmauer@uphs.upenn.edu 

Utah
      Utah Cancer Specialists - Administrative Office, Salt Lake City,  Utah,  84106,  United States; Recruiting
W. Graydon Harker, MD  801-269-0231 

Study chairs or principal investigators

James R. Berenson, MD,  Study Chair,  Oncotherapeutics   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000368637; ONCOTHER-MAC001; NCT00085345
Record last reviewed:  September 2004
Last Updated:  April 5, 2005
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00085345
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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