Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients

NCT00661544 | Completed Phase 1 Results

• 1 other identifier: 2003-0603
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To evaluate the efficacy of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma
3. 3.To determine the effects of arsenic trioxide on melphalan pharmacokinetics

Conditions

Multiple Myeloma; Stem Cell Transplantation

Keywords

Multiple Myeloma; Ascorbic Acid; Vitamin C; Arsenic Trioxide; Trisenox; Melphalan; Autologous Stem Cell Transplant; Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Bone marrow aspirate and biopsy performed to assess complete response and overall response rate.

  3, 6 and 12 months

Study Arms (1)

Arsenic Trioxide + Vitamin C + Melphalan

EXPERIMENTAL

Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)

Drug: Arsenic Trioxide; Drug: Melphalan; Drug: Ascorbic Acid

Interventions

Arsenic Trioxide DRUG

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.

Also known as: Trisenox

Arsenic Trioxide + Vitamin C + Melphalan

Melphalan DRUG

Dose Levels 1, 2, \& 3: 100 mg/m2 IV Days -4, -3.

Arsenic Trioxide + Vitamin C + Melphalan

Ascorbic Acid DRUG

Dose Levels 1, 2, \& 3: 1000 mg IV Days -9 to -3.

Also known as: Vitamin C

Arsenic Trioxide + Vitamin C + Melphalan

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Performance Status (PS) of \<2.
• Left ventricular ejection fraction \>40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
• 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.
• 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.
• HIV-negative.
• Patient is not pregnant.
• Patient or guardian able to sign informed consent.
• Corrected QT interval less than 500 msec.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• CTI BioPharma: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas (UT) MD Anderson Cancer Center official website

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Arsenic Trioxide; Melphalan; Ascorbic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Muzaffar H. Qazilbash, MD / Associate Professor
• Organization: U.T. M.D. Anderson Cancer Center

713-745-3458

Study Officials

• Muzaffar H. Qazilbash, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 18, 2008
• Study Start: March 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: March 4, 2013
• Results First Posted: July 14, 2009

Record last verified: 2013-02

Locations

US (1)