Arsenic Trioxide in Treating Patients With Multiple Myeloma
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma and Plasma Cell Neoplasm
Intervention: arsenic trioxide (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: CTI BioPharma Official(s) and/or principal investigator(s): Carolyn Paradise, MD, Study Chair, Affiliation: CTI BioPharma
Summary
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.
Clinical Details
Official title: Phase II Study of Arsenic Trioxide in Patients With Multiple Myeloma
Study design: Primary Purpose: Treatment
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Scripps Clinic, La Jolla, California 92037, United States
Rocky Mountain Cancer Center, Denver, Colorado 80218, United States
Georgia Cancer Specialist, Marietta, Georgia 30060, United States
University of Illinois at Chicago, Chicago, Illinois 60612, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States
Swedish Cancer Institute, Seattle, Washington 98104, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 2001
Last updated: November 16, 2008
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