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

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
arsenic trioxide
dexamethasone
Sponsored by
CTI BioPharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Clinical Research Center
  • Highlands Oncology Group - Springdale
  • St. Joseph Hospital Regional Cancer Center - Orange
  • Stockton Hematology Oncology Medical Group
  • Rocky Mountain Cancer Centers - Midtown
  • Pasco Pinellas Cancer Center - Tarpon Springs
  • Winship Cancer Institute of Emory University
  • Mountain States Tumor Institute - Boise
  • Memorial Sloan-Kettering Cancer Center
  • Texas Cancer Care

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
October 2, 2020
Sponsor
CTI BioPharma
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00017069
Brief Title
Arsenic Trioxide and Dexamethasone in Treating Patients With Recurrent or Refractory Stage II or Stage III Multiple Myeloma
Official Title
CTI 1060: A Phase II Clinical Trial of Arsenic Trioxide and Dexamethasone as Therapy for Relapsed or Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Study Start Date
February 2001 (Actual)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CTI BioPharma
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
refractory multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
arsenic trioxide
Intervention Type
Drug
Intervention Name(s)
dexamethasone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott C. Stromatt, MD
Organizational Affiliation
CTI BioPharma
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Highlands Oncology Group - Springdale
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
St. Joseph Hospital Regional Cancer Center - Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868-3849
Country
United States
Facility Name
Stockton Hematology Oncology Medical Group
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Pasco Pinellas Cancer Center - Tarpon Springs
City
Tarpon Springs
State/Province
Florida
ZIP/Postal Code
34689
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Mountain States Tumor Institute - Boise
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Texas Cancer Care
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States

12. IPD Sharing Statement

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

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