Overview

Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
CTI BioPharma
Treatments:
Arsenic Trioxide
Ascorbic Acid
Melphalan
Vitamins
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.