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Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00661544
First Posted: April 18, 2008
Last Update Posted: March 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CTI BioPharma
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
  1. To evaluate the toxicity and safety of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma
  2. To evaluate the efficacy of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma
  3. To determine the effects of arsenic trioxide on melphalan pharmacokinetics

Condition Intervention Phase
Multiple Myeloma Stem Cell Transplantation Drug: Arsenic Trioxide Drug: Melphalan Drug: Ascorbic Acid Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of the Combination of Arsenic Trioxide With Ascorbic Acid and High-Dose Melphalan for Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 3, 6 and 12 months ]
    Bone marrow aspirate and biopsy performed to assess complete response and overall response rate.


Enrollment: 48
Study Start Date: March 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arsenic Trioxide + Vitamin C + Melphalan
Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
Drug: Arsenic Trioxide
Dose Level 1: None; Dose Level 2: 0.15 mg/kg days Intravenous (IV) Days -9 to -3; Dose Level 3: 0.25 mg/kg days IV Days -9 to -3.
Other Name: Trisenox
Drug: Melphalan
Dose Levels 1, 2, & 3: 100 mg/m2 IV Days -4, -3.
Drug: Ascorbic Acid
Dose Levels 1, 2, & 3: 1000 mg IV Days -9 to -3.
Other Name: Vitamin C

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with Multiple Myeloma in any of the following disease categories: a) Primary Refractory Disease b) Consolidation of a partial remission (defined as a decrease but continued presence of monoclonal protein on serum and urine immunofixation electrophoresis, and/or the presence of plasmacytosis on bone marrow aspirate and biopsy) c) All patients relapsing after prior therapy .
  2. Age up to 70 years.
  3. Zubrod Performance Status (PS) of <2.
  4. Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
  5. Forced vital capacity (FVC); Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DL CO) >40%. No symptomatic pulmonary disease.
  6. Serum bilirubin <2 times upper limit of normal, SGPT <4 times upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites >1L prior to drainage.
  7. HIV-negative.
  8. Patient is not pregnant.
  9. Patient or guardian able to sign informed consent.
  10. Corrected QT interval less than 500 msec.

Exclusion Criteria:

  1. Corrected QT interval greater than 500 msec
  2. Patients in complete remission (defined as the absence of monoclonal protein on serum and urine immunofixation electrophoresis, and the absence of plasmacytosis in bone marrow aspirate and biopsy).
  3. Patients with non-secretory myeloma.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661544


Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
CTI BioPharma
Investigators
Principal Investigator: Muzaffar H. Qazilbash, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00661544     History of Changes
Other Study ID Numbers: 2003-0603
First Submitted: April 15, 2008
First Posted: April 18, 2008
Results First Submitted: March 13, 2009
Results First Posted: July 14, 2009
Last Update Posted: March 4, 2013
Last Verified: February 2013

Keywords provided by M.D. Anderson Cancer Center:
Multiple Myeloma
Ascorbic Acid
Vitamin C
Arsenic Trioxide
Trisenox
Melphalan
Autologous Stem Cell Transplant
Stem Cell Transplantation

Additional relevant MeSH terms:
Ascorbic Acid
Arsenic trioxide
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Vitamins
Melphalan
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Antioxidants
Protective Agents