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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

Page last updated: August 23, 2015

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