Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining arsenic trioxide and dexamethasone in treating patients who have recurrent or refractory stage II or stage III multiple myeloma.
Multiple Myeloma and Plasma Cell Neoplasm
Drug: arsenic trioxide
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma|
|Study Start Date:||February 2001|
- Determine the response rate of patients with recurrent or refractory stage II or III multiple myeloma treated with arsenic trioxide and dexamethasone.
- Determine the rates of overall and relapse-free survival in patients treated with this regimen.
- Determine the safety profile of this treatment regimen in these patients.
OUTLINE: Patients receive arsenic trioxide IV daily for 5 days during the first week only and then 2 days a week thereafter. Patients also receive IV or oral dexamethasone on days 1-4 every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Disease assessments are conducted every 4 weeks. Patients achieving complete response (CR) receive 2 additional courses of therapy after initial determination of CR.
Final assessments are conducted 4 weeks after the last study treatment and then annually thereafter.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017069
|United States, Arizona|
|Arizona Clinical Research Center|
|Tucson, Arizona, United States, 85712|
|United States, Arkansas|
|Highlands Oncology Group - Springdale|
|Springdale, Arkansas, United States, 72764|
|United States, California|
|St. Joseph Hospital Regional Cancer Center - Orange|
|Orange, California, United States, 92868-3849|
|Stockton Hematology Oncology Medical Group|
|Stockton, California, United States, 95204|
|United States, Colorado|
|Rocky Mountain Cancer Centers - Midtown|
|Denver, Colorado, United States, 80218|
|United States, Florida|
|Pasco Pinellas Cancer Center - Tarpon Springs|
|Tarpon Springs, Florida, United States, 34689|
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, Idaho|
|Mountain States Tumor Institute - Boise|
|Meridian, Idaho, United States, 83642|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Texas|
|Texas Cancer Care|
|Fort Worth, Texas, United States, 76104|
|Study Chair:||Scott C. Stromatt, MD||CTI BioPharma|