Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma
This trial is active, not recruiting.
|Condition||multiple myeloma and plasma cell neoplasm|
|Treatments||arsenic trioxide, dexamethasone|
|Collaborator||National Cancer Institute (NCI)|
|Start date||February 2001|
|Trial identifier||NCT00017069, CDR0000068646, CTI-1060, MSKCC-01012, NCI-G01-1951|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Tucson, AZ||Arizona Clinical Research Center||no longer recruiting|
|Springdale, AR||Highlands Oncology Group - Springdale||no longer recruiting|
|Orange, CA||St. Joseph Hospital Regional Cancer Center - Orange||no longer recruiting|
|Stockton, CA||Stockton Hematology Oncology Medical Group||no longer recruiting|
|Denver, CO||Rocky Mountain Cancer Centers - Midtown||no longer recruiting|
|Tarpon Springs, FL||Pasco Pinellas Cancer Center - Tarpon Springs||no longer recruiting|
|Atlanta, GA||Winship Cancer Institute of Emory University||no longer recruiting|
|Meridian, ID||Mountain States Tumor Institute - Boise||no longer recruiting|
|New York, NY||Memorial Sloan-Kettering Cancer Center||no longer recruiting|
|Fort Worth, TX||Texas Cancer Care||no longer recruiting|
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Diagnosis of stage II or III multiple myeloma - Refractory myeloma defined as progressive disease (more than 25% increase in M protein or in radiographic findings of nonsecretory myeloma) despite up to 3 courses of prior cytotoxic chemotherapy - No more than 3 prior cytotoxic regimens - No more than 1 prior high-dose cytotoxic regimen with stem cell transplantation - History of disease progression after prior steroid antimyeloma therapy - No smoldering myeloma - Measurable disease based on presence of serum and urine M protein and/or measurable plasmacytoma PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - Karnofsky 70-100% Life expectancy: - At least 3 months Hematopoietic: - Absolute granulocyte count greater than 1,200/mm^3* - Platelet count greater than 75,000/mm^3* - Hemoglobin greater than 10 g/dL* NOTE: *Unless due to multiple myeloma Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGOT and SGPT no greater than 2 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels - No significant underlying cardiac dysfunction - No conduction defects - No unstable angina - No congestive heart failure - No New York Heart Association class II-IV cardiac disease - No myocardial infarction within the past 6 months Other: - No preexisting grade 2 or greater neurotoxicity/neuropathy - No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer - No uncontrolled diabetes mellitus - No active serious infection uncontrolled by antibiotics - No history of grand mal seizures (other than infantile febrile seizures) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - See Chemotherapy - At least 28 days since prior biologic therapy Chemotherapy: - See Disease Characteristics - At least 28 days since prior cytotoxic chemotherapy, including high-dose cytotoxic regimen with stem cell transplantation - No other concurrent cytotoxic chemotherapy Endocrine therapy: - See Disease Characteristics Radiotherapy: - At least 28 days since prior radiotherapy except for focal radiation for symptom control Surgery: - Not specified
|Official title||CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma|
|Description||OBJECTIVES: - 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.|
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