NCT00081133

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in 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 their growth. Combining arsenic trioxide with imatinib mesylate may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide when given with imatinib mesylate and to see how well they work in treating patients with accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

April 7, 2004

Last Update Submit

June 4, 2013

Conditions

Leukemia

Keywords

accelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiarecurrent adult acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemia

Interventions

arsenic trioxideDRUG
imatinib mesylateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of one of the following: * Chronic myelogenous leukemia (CML) in one of the following phases: * Blastic phase\* * Accelerated phase\* * No appropriate donors for stem cell transplantation NOTE: \*Must have received high-dose (600-800 mg/day) imatinib mesylate of no more than 3 months duration * Acute lymphoblastic leukemia * Philadelphia chromosome positive by cytogenetic confirmation * Patients with only bcr-abl-positive disease by polymerase chain reaction are not eligible * \> 10% blasts in the bone marrow * No isolated extramedullary disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * AST ≤ 2 times ULN * INR and PTT ≤ 1.5 times ULN (except for patients on anticoagulation therapy) Renal * Creatinine ≤ 2 times ULN Cardiovascular * Baseline QTc intervals \< 480 ms * No chronic arrhythmias * No active coronary artery disease Other * No chronic electrolyte abnormalities * No prior non-compliance to medical regimens * No patients who are considered potentially unreliable * No active serious infection * No other active malignancies except superficial epithelial cancers * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for at least 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No prior peripheral blood stem cell or bone marrow transplantation Chemotherapy * Prior hydroxyurea allowed * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * More than 4 weeks since prior major surgery and recovered Other * Prior anagrelide allowed * No concurrent warfarin for therapeutic anticoagulation * Concurrent low molecular weight heparin is allowed

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Accelerated PhaseBlast CrisisPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Arsenic TrioxideImatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ellin Berman, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2004

First Posted

April 8, 2004

Study Start

December 1, 2003

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)