Arsenic Trioxide in Treating Patients With Multiple Myeloma

Sponsor
CTI BioPharma (Industry)
Overall Status
Terminated
CT.gov ID
NCT00017433
Collaborator
(none)
6
48

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: arsenic trioxide
Phase 2

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Study of Arsenic Trioxide in Patients With Multiple Myeloma
Actual Study Start Date :
Jan 1, 2001
Actual Primary Completion Date :
Jan 1, 2005
Actual Study Completion Date :
Jan 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

    Site City State Country Postal Code
    1 Scripps Clinic La Jolla California United States 92037
    2 Rocky Mountain Cancer Center Denver Colorado United States 80218
    3 Georgia Cancer Specialist Marietta Georgia United States 30060
    4 University of Illinois at Chicago Chicago Illinois United States 60612
    5 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    6 Swedish Cancer Institute Seattle Washington United States 98104

    Sponsors and Collaborators

    • CTI BioPharma

    Investigators

    • Study Chair: Carolyn Paradise, MD, CTI BioPharma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00017433
    Other Study ID Numbers:
    • CTI-1057
    • CDR0000068688
    First Posted:
    Jan 8, 2004
    Last Update Posted:
    Oct 6, 2020
    Last Verified:
    Oct 1, 2020

    Study Results

    No Results Posted as of Oct 6, 2020