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

Sponsors and Collaborators:	M.D. Anderson Cancer Center 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:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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:

To find if the combination of Trisenox (arsenic trioxide), ascorbic acid (vitamin C), and high dose melphalan is safe and effective for patients with multiple myeloma undergoing high-dose therapy and autologous stem cell transplantation. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Optional additional blood draws to determine if arsenic trioxide affects the levels of melphalan in the blood when administered together. These tests will also measure the levels of enzymes that may help eliminate the effects of arsenic. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Optional blood draw samples will also be used to determine the degree of DNA damage caused by melphalan, and its relationship with the outcome. [ Time Frame: 3 Years ] [ 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
1: Experimental 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. 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.

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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

U.T.M.D. Anderson Cancer Center

More Information

No publications provided

Responsible Party:	U.T. M.D. Anderson Cancer Center ( Muzaffar H. Qazilbash, MD/Associate Professor )
Study ID Numbers:	2003-0603
Study First Received:	April 15, 2008
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00661544 History of Changes
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

Study placed in the following topic categories:

Melphalan
Antioxidants
Immunoproliferative Disorders
Immunologic Factors
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Arsenic trioxide
Trace Elements
Paraproteinemias
Hemostatic Disorders

Immunosuppressive Agents
Multiple Myeloma
Vitamin C
Hemorrhagic Disorders
Vitamins
Antineoplastic Agents, Alkylating
Micronutrients
Lymphoproliferative Disorders
Alkylating Agents
Ascorbic Acid
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Melphalan
Antioxidants
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Paraproteinemias
Hemostatic Disorders
Hemorrhagic Disorders
Therapeutic Uses
Vitamins
Cardiovascular Diseases
Micronutrients
Alkylating Agents

Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Hematologic Diseases
Growth Substances
Vascular Diseases
Arsenic trioxide
Immunosuppressive Agents
Protective Agents
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on July 02, 2009