Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma

October 2, 2020 updated by: CTI BioPharma

CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group - Springdale
    • California
      • Orange, California, United States, 92868-3849
        • St. Joseph Hospital Regional Cancer Center - Orange
      • Stockton, California, United States, 95204
        • Stockton Hematology Oncology Medical Group
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers - Midtown
    • Florida
      • Tarpon Springs, Florida, United States, 34689
        • Pasco Pinellas Cancer Center - Tarpon Springs
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Mountain States Tumor Institute - Boise
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Texas Cancer Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CTI BioPharma

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Scott C. Stromatt, MD, CTI BioPharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2001

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

June 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTI-1060
  • CDR0000068646 (Registry Identifier: PDQ (Physician Data Query))
  • MSKCC-01012
  • NCI-G01-1951

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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