A Phase 2 interventional study of arsenic trioxide and ascorbic acid in Stage II Multiple Myeloma, Stage III Multiple Myeloma and Refractory Plasma Cell Neoplasm, sponsored by Oncotherapeutics. Withdrawn at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-10.
Sponsored by Oncotherapeutics · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
Browse Multiple Myeloma studies →Oncotherapeutics is the lead sponsor of 22 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
This study is withdrawn, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.
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Oncotherapeutics