NCT00066326

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as 17-N-allylamino-17-demethoxygeldanamycin use different ways to stop cancer cells from dividing so they stop growing or die. Combining imatinib mesylate with chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin when given together with imatinib mesylate in treating patients with chronic myelogenous leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 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

June 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

1.3 years

First QC Date

August 6, 2003

Last Update Submit

April 3, 2013

Conditions

Leukemia

Keywords

blastic phase chronic myelogenous leukemiaPhiladelphia chromosome positive chronic myelogenous leukemiachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemia

Interventions

imatinib mesylateDRUG
tanespimycinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of chronic myelogenous leukemia, including any of the following phases: * Blastic phase * Greater than 30% blasts in the peripheral blood or bone marrow * Previously untreated disease OR refractory to or relapsed after most recent therapy * Accelerated phase, defined by 1 of the following: * At least 15, but less than 30%, blasts in the peripheral blood or bone marrow * At least 30% blasts and promyelocytes in the peripheral blood or bone marrow * Greater than 20% peripheral blood basophilia * Chronic phase * No major cytogenetic response (less than 65% Philadelphia chromosome negative) after 12 months of prior imatinib mesylate therapy * Philadelphia chromosome positive by routine cytogenetics PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Not specified Hepatic * Bilirubin no greater than 1.5 mg/dL * ALT and AST no greater than 2.5 times upper limit of normal Renal * Creatinine less than 1.5 mg/dL Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known allergy to eggs * Able to swallow pills * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled medical illness PRIOR CONCURRENT THERAPY: Biologic therapy * No prior stem cell transplantation Chemotherapy * More than 4 weeks since prior chemotherapy (except hydroxyurea or anagrelide) (at least 6 weeks for nitrosoureas or mitomycin) Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * No prior liver, kidney, or lung transplantation * More than 14 days since prior major surgery (e.g., thoracotomy or intra-abdominal surgery) Other * Prior imatinib mesylate administered within the past 4 weeks is allowed * No concurrent tacrolimus or cyclosporine as immunosuppressive agents * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent agents that alter CYP3A4 activity, including any of the following: * Grapefruit juice * Ketoconazole * Fluconazole * Itraconazole * Erythromycin * Clarithromycin * Cimetidine * Terfenadine * Astemizole * HIV protease inhibitors (e.g., indinavir and nelfinavir)

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

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

LeukemiaBlast CrisisLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated Phase

Interventions

Imatinib Mesylatetanespimycin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Charles A. Schiffer, MD

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

June 1, 2003

Primary Completion

October 1, 2004

Study Completion

September 1, 2005

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

US(1)