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Arsenic Trioxide in Treating Patients With Multiple Myeloma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00017433
First Posted: January 8, 2004
Last Update Posted: November 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: arsenic trioxide Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Arsenic Trioxide in Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2001
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017433


Locations
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Georgia
Georgia Cancer Specialist
Marietta, Georgia, United States, 30060
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
CTI BioPharma
Investigators
Study Chair: Carolyn Paradise, MD CTI BioPharma
  More Information

ClinicalTrials.gov Identifier: NCT00017433     History of Changes
Other Study ID Numbers: CDR0000068688
CTI-1057
First Submitted: June 6, 2001
First Posted: January 8, 2004
Last Update Posted: November 18, 2008
Last Verified: June 2002

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Arsenic trioxide
Antineoplastic Agents