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.
Full Title of Study: “CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma”
- Study Type: Interventional
- Study Design
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 2005
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.
- Drug: arsenic trioxide
- Drug: dexamethasone
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 120 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- CTI BioPharma
- National Cancer Institute (NCI)
- Overall Official(s)
- Scott C. Stromatt, MD, Study Chair, CTI BioPharma
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