Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Cell Therapeutics
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00661544

Purpose

To evaluate the toxicity and safety of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma
To evaluate the efficacy of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma
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 I Phase II

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:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Arsenic Cancer Multiple Myeloma Vitamin C

Drug Information available for: Ascorbic acid Melphalan Sarcolysin Arsenic trioxide Melphalan hydrochloride

U.S. FDA Resources

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 ]

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 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

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Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 .
Age up to 70 years.
Zubrod PS of <2.
Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
FEV1, FVC and DLCO >40%. No symptomatic pulmonary disease.
Serum bilirubin <2 X upper limit of normal, SGPT <4 X upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites >1L prior to drainage.
HIV-negative.
Patient is not pregnant.
Patient or guardian able to sign informed consent.
Corrected QT interval less than 500 msec.

Exclusion Criteria:

Corrected QT interval greater than 500 msec
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).
Patients with non-secretory myeloma.

Contacts and Locations

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

Cell Therapeutics

Investigators

Principal Investigator:

Muzaffar H. Qazilbash, MD

M.D. Anderson Cancer Center

More Information

No publications provided

Responsible Party:	Muzaffar H. Qazilbash, MD/Associate Professor, U.T. 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:	May 21, 2009
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:

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
Ascorbic Acid

Vitamins
Melphalan
Arsenic trioxide
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012