search
Back to results

Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
arsenic trioxide
imatinib mesylate
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Cytogenetically confirmed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia, meeting one of the following criteria: Chronic phase Less than 15% blasts in peripheral blood or marrow Less than 30% blasts and promyelocytes in peripheral blood or marrow Less than 20% basophils in blood or marrow Platelet count at least 100,000/mm^3 (unless therapy related) No progressive (increase of at least 10 cm in any 4 of the past 24 weeks) or existing (greater than 10 cm) splenomegaly Complete hematologic response (CHR) No immature myeloid cells in peripheral blood No increased basophils in peripheral blood WBC less than upper limit of normal (ULN) Platelet count less than ULN No major (less than 35% Ph+) or complete (0% Ph+) cytogenetic response after at least 6 months of imatinib mesylate Loss of prior major cytogenetic response or failure to achieve major cytogenetic response PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin less than 1.5 times ULN AST or ALT less than 2.5 times ULN Renal Creatinine less than 1.5 times ULN Cardiovascular No New York Heart Association grade III or IV congestive heart failure No untreated symptomatic cardiac ischemia No underlying cardiac arrhythmia, including but not limited to any of the following: Conduction abnormality/atrioventricular heart block Nodal/junctional arrhythmia/dysrhythmia Sinus bradycardia or tachycardia Supraventricular tachycardia Ventricular arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 methods of effective barrier contraception during and for 3 months after study Electrolyte levels (especially potassium and magnesium) normal (CHR patients) No history of noncompliance that would preclude study participation No other concurrent serious, uncontrolled medical condition No grade 2 or greater neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 14 days since prior therapy except hydroxyurea, anagrelide hydrochloride, or imatinib mesylate More than 28 days since prior investigational agents No concurrent grapefruit or grapefruit juice

Sites / Locations

  • UCLA Department of Medicine, Division of Hematology/Oncology
  • H. Lee Moffitt Cancer Center
  • OHSU Knight Cancer Institute

Outcomes

Primary Outcome Measures

Satey and Tolerability
Dose-limiting toxicity
Pharmacokinetics

Secondary Outcome Measures

Full Information

First Posted
January 27, 2003
Last Updated
May 24, 2012
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00053248
Brief Title
Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
Official Title
A Phase I/II Study To Determine The Safety, Tolerability, And Anti-Leukemic Effects of Trisenox (Arsenic Trioxide) In Combination With Gleevec (STI571) In Patients With Resistant Chronic Myelogenous Leukemia In Chronic Phase
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

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. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining chemotherapy with imatinib mesylate may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining arsenic trioxide with imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia.
Detailed Description
OBJECTIVES: Determine the safety and tolerability of arsenic trioxide and imatinib mesylate in patients with resistant chronic phase chronic myelogenous leukemia. Determine potential dose-limiting toxic effects in patients treated with this regimen. Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral imatinib mesylate once daily and arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and then twice weekly. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-24 patients (at least 6 patients for phase I and at least 12 patients for phase II) 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
Leukemia
Keywords
chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
arsenic trioxide
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Primary Outcome Measure Information:
Title
Satey and Tolerability
Title
Dose-limiting toxicity
Title
Pharmacokinetics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Cytogenetically confirmed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia, meeting one of the following criteria: Chronic phase Less than 15% blasts in peripheral blood or marrow Less than 30% blasts and promyelocytes in peripheral blood or marrow Less than 20% basophils in blood or marrow Platelet count at least 100,000/mm^3 (unless therapy related) No progressive (increase of at least 10 cm in any 4 of the past 24 weeks) or existing (greater than 10 cm) splenomegaly Complete hematologic response (CHR) No immature myeloid cells in peripheral blood No increased basophils in peripheral blood WBC less than upper limit of normal (ULN) Platelet count less than ULN No major (less than 35% Ph+) or complete (0% Ph+) cytogenetic response after at least 6 months of imatinib mesylate Loss of prior major cytogenetic response or failure to achieve major cytogenetic response PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin less than 1.5 times ULN AST or ALT less than 2.5 times ULN Renal Creatinine less than 1.5 times ULN Cardiovascular No New York Heart Association grade III or IV congestive heart failure No untreated symptomatic cardiac ischemia No underlying cardiac arrhythmia, including but not limited to any of the following: Conduction abnormality/atrioventricular heart block Nodal/junctional arrhythmia/dysrhythmia Sinus bradycardia or tachycardia Supraventricular tachycardia Ventricular arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 methods of effective barrier contraception during and for 3 months after study Electrolyte levels (especially potassium and magnesium) normal (CHR patients) No history of noncompliance that would preclude study participation No other concurrent serious, uncontrolled medical condition No grade 2 or greater neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 14 days since prior therapy except hydroxyurea, anagrelide hydrochloride, or imatinib mesylate More than 28 days since prior investigational agents No concurrent grapefruit or grapefruit juice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Mauro, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Department of Medicine, Division of Hematology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

We'll reach out to this number within 24 hrs