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Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients

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ClinicalTrials.gov Identifier: NCT00661544
Recruitment Status : Completed
First Posted : April 18, 2008
Results First Posted : July 14, 2009
Last Update Posted : March 4, 2013
Sponsor:
Collaborator:
CTI BioPharma
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
  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 or disease Intervention/treatment Phase
Multiple Myeloma Stem Cell Transplantation Drug: Arsenic Trioxide Drug: Melphalan Drug: Ascorbic Acid Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
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
Study Start Date : March 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007


Arm Intervention/treatment
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



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



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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.

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00661544     History of Changes
Other Study ID Numbers: 2003-0603
First Posted: April 18, 2008    Key Record Dates
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:
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
Ascorbic Acid
Melphalan
Arsenic trioxide
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