Melphalan, Arsenic Trioxide, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma
RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs.
PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.
|Stage II Multiple Myeloma Stage III Multiple Myeloma Refractory Plasma Cell Neoplasm||Drug: arsenic trioxide Drug: ascorbic acid Drug: melphalan Procedure: chemosensitization/potentiation Procedure: chemotherapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma|
- Determine the time to progression in patients with relapsed or refractory multiple myeloma (MM) treated with melphalan, arsenic trioxide, and ascorbic acid.
- Determine the response rate (combined complete response, partial response, and minimal response) in patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the time to response and overall survival of patients treated with this regimen.
- Determine the effects of this regimen on renal failure associated with MM in these patients.
OUTLINE: This is an open-label, non-randomized, multicenter study.
Patients receive oral melphalan once daily on days 1-4 of week 1 and arsenic trioxide (ATO) IV over 1-2 hours and ascorbic acid IV over 15 minutes on days 1-4 of week 1 and then twice weekly during weeks 2-5. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression any time after course 1 also receive oral prednisone once daily on days 1-4 and 22-25 of each course. Patients achieving a complete response after 6 courses of therapy undergo bone marrow biopsy and receive no further therapy. Patients achieving stable disease or a partial response after 6 courses of therapy continue to receive ATO and ascorbic acid once weekly.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085345
|United States, Arizona|
|Palo Verde Hematology Oncology|
|Glendale, Arizona, United States, 85304|
|United States, California|
|Comprehensive Blood and Cancer Center|
|Bakersfield, California, United States, 93309-0633|
|Southbay Oncology / Hematology Medical Group|
|Campbell, California, United States, 95008|
|Fountain Valley, California, United States, 92708|
|Hematology-Oncology Medical Group of Fresno, Incorporated|
|Fresno, California, United States, 93720|
|Hematology Oncology Medical Group of Orange County, Incorporated|
|Orange, California, United States, 92868|
|Cancer Care Associates Medical Group - Redondo Beach|
|Redondo Beach, California, United States, 90277|
|Redwood Regional Oncology Center - Sotoyome|
|Santa Rosa, California, United States, 95405|
|Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital|
|Soquel, California, United States, 95073|
|San Diego Cancer Center - Vista|
|Vista, California, United States, 92083|
|West Hollywood, California, United States, 90069|
|United States, Florida|
|Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center|
|Miami Beach, Florida, United States, 33140|
|United States, Georgia|
|Atlanta Cancer Care - Roswell|
|Roswell, Georgia, United States, 30076|
|United States, Louisiana|
|Tulane Cancer Center at Tulane University Hospital and Clinic|
|New Orleans, Louisiana, United States, 70112-2699|
|United States, Maryland|
|Center for Cancer and Blood Disorders at Suburban Hospital|
|Bethesda, Maryland, United States, 20817|
|United States, Michigan|
|William Beaumont Hospital - Royal Oak Campus|
|Royal Oak, Michigan, United States, 48073|
|United States, New Jersey|
|Hackensack University Medical Center Cancer Center|
|Hackensack, New Jersey, United States, 07601|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Utah|
|Utah Cancer Specialists - Administrative Office|
|Salt Lake City, Utah, United States, 84106|
|Study Chair:||James R. Berenson, MD||Oncotherapeutics|