Arsenic Trioxide in Treating Patients With Multiple Myeloma
This trial is active, not recruiting.
|Condition||multiple myeloma and plasma cell neoplasm|
|Start date||January 2001|
|Trial identifier||NCT00017433, CDR0000068688, CTI-1057|
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory stage II or stage III multiple myeloma.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|La Jolla, CA||Scripps Clinic||no longer recruiting|
|Denver, CO||Rocky Mountain Cancer Center||no longer recruiting|
|Marietta, GA||Georgia Cancer Specialist||no longer recruiting|
|Chicago, IL||University of Illinois at Chicago||no longer recruiting|
|Cleveland, OH||Cleveland Clinic Taussig Cancer Center||no longer recruiting|
|Seattle, WA||Swedish Cancer Institute||no longer recruiting|
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma Stage II or III (Durie-Salmon) Relapsed or refractory to conventional therapy No monoclonal gammopathy or indolent or smoldering myeloma Measurable disease by serum and urine M protein and/or plasmacytoma PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: 3 months Hematopoietic: Granulocyte count greater than 1,200/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT/SGPT less than 2 times ULN Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels PRIOR CONCURRENT THERAPY: Biologic therapy: At least 28 days since prior biologic therapy Chemotherapy: No more than 3 prior chemotherapy regimens, including no more than 2 cytotoxic regimens AND 1 high-dose cytotoxic regimen as part of stem cell transplantation Endocrine therapy: At least 28 days since prior endocrine therapy Radiotherapy: At least 28 days since prior radiotherapy (except for focal radiotherapy for symptom control) Surgery: Not specified
|Official title||Phase II Study of Arsenic Trioxide in Patients With Multiple Myeloma|
|Description||OBJECTIVES: I. Determine the response rate of patients with relapsed or refractory stage II or III multiple myeloma treated with arsenic trioxide. II. Determine the overall and relapse-free survival rates of patients treated with this drug. III. Determine the safety profile of this drug in these patients. OUTLINE: Patients receive arsenic trioxide IV on days 1-5 and 8-12. Treatment repeats every 4 weeks for up to 6 courses. Patients are followed at 4 weeks after the last treatment dose. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.|
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