NCT00053248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_1 leukemia

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

May 28, 2012

Status Verified

June 1, 2010

Enrollment Period

2.7 years

First QC Date

January 27, 2003

Last Update Submit

May 24, 2012

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemiaPhiladelphia chromosome positive chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (3)

  • Satey and Tolerability

  • Dose-limiting toxicity

  • Pharmacokinetics

Interventions

arsenic trioxideDRUG
imatinib mesylateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

UCLA Department of Medicine, Division of Hematology/Oncology

Los Angeles, California, 90095, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Arsenic TrioxideImatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen CompoundsBenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Michael Mauro, MD

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2003

First Posted

January 28, 2003

Study Start

October 1, 2002

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

May 28, 2012

Record last verified: 2010-06

Locations

US(3)