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Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients

This study has been completed.
Sponsor:
Collaborator:
CTI BioPharma
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00661544
First received: April 15, 2008
Last updated: February 26, 2013
Last verified: February 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00661544     History of Changes
Other Study ID Numbers: 2003-0603
Study First Received: April 15, 2008
Results First Received: March 13, 2009
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

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:
Arsenic trioxide
Ascorbic Acid
Multiple Myeloma
Neoplasms, Plasma Cell
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
Melphalan
Vitamins
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antioxidants
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014