NCT00025415

Brief Summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have advanced cancer and liver dysfunction

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

3.4 years

First QC Date

October 11, 2001

Last Update Submit

February 6, 2013

Conditions

Accelerated Phase Chronic Myelogenous LeukemiaAcute Undifferentiated LeukemiaAIDS-related Peripheral/Systemic LymphomaAIDS-related Primary CNS LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-cell LymphomaAtypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeBlastic Phase Chronic Myelogenous LeukemiaChildhood Myelodysplastic SyndromesChronic Eosinophilic LeukemiaChronic Myelogenous Leukemia, BCR-ABL1 PositiveChronic Myelomonocytic LeukemiaChronic Neutrophilic LeukemiaChronic Phase Chronic Myelogenous Leukemiade Novo Myelodysplastic SyndromesEssential ThrombocythemiaExtramedullary PlasmacytomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueGastrointestinal Stromal TumorIntraocular LymphomaIsolated Plasmacytoma of BoneMeningeal Chronic Myelogenous LeukemiaMonoclonal Gammopathy of Undetermined SignificanceMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiableNodal Marginal Zone B-cell LymphomaPolycythemia VeraPreviously Treated Myelodysplastic SyndromesPrimary Central Nervous System Non-Hodgkin LymphomaPrimary MyelofibrosisPrimary Systemic AmyloidosisProgressive Hairy Cell Leukemia, Initial TreatmentProlymphocytic LeukemiaRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRefractory Multiple MyelomaRelapsing Chronic Myelogenous LeukemiaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromesSmall Intestine LymphomaSplenic Marginal Zone LymphomaStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Mixed Cell LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Adult Hodgkin LymphomaStage IV Adult Immunoblastic Large Cell LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Adult T-cell Leukemia/LymphomaStage IV Chronic Lymphocytic LeukemiaStage IV Cutaneous T-cell Non-Hodgkin LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Mycosis Fungoides/Sezary SyndromeStage IV Small Lymphocytic LymphomaT-cell Large Granular Lymphocyte LeukemiaUnspecified Adult Solid Tumor, Protocol SpecificUntreated Adult Acute Lymphoblastic LeukemiaUntreated Adult Acute Myeloid LeukemiaUntreated Hairy Cell LeukemiaWaldenström Macroglobulinemia

Outcome Measures

Primary Outcomes (2)

  • MTD defined based on the toxicities observed during the first cycle of treatment

    4 weeks

  • Toxicity evaluation graded according to the NCI common toxicity criteria and relationship to the study drug

    Results will be tabulated by liver dysfunction group.

    Up to 4 years

Secondary Outcomes (3)

  • Pharmacokinetic data

    Day 1, 2, 3, 4, 15, 16

  • Responses

    Up to 4 years

  • Child-Pugh Classification

    Baseline

Study Arms (1)

Treatment (imatinib mesylate)

EXPERIMENTAL

Patients receive oral imatinib mesylate daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients within each stratum (except normal stratum) receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity

Drug: imatinib mesylateOther: pharmacological study

Interventions

imatinib mesylateDRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec
Treatment (imatinib mesylate)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (imatinib mesylate)

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed surgically incurable solid tumor orhematologic malignancy for which no standard or palliative therapy exists oris no longer effective
  • All tumor types are eligible, including:
  • Chronic myelogenous leukemia or other Philadelphia chromosome-positive leukemia OR
  • Gastrointestinal stromal tumors
  • Patients with gliomas that require corticosteroids or anticonvulsants must beon a stable dose and seizure-free for 1 month
  • No unstable or untreated (non-irradiated) brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 3 months
  • WBC at least 3,000/mm\^3
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • No active hemolysis
  • See Surgery
  • No evidence of biliary sepsis
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated PhaseLeukemia, Biphenotypic, AcuteLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseThrombocythemia, EssentialGastrointestinal Stromal TumorsIntraocular LymphomaMonoclonal Gammopathy of Undetermined SignificanceMyeloproliferative DisordersLymphoma, B-Cell, Marginal ZonePolycythemia VeraPrimary MyelofibrosisImmunoglobulin Light-chain AmyloidosisLeukemia, ProlymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellMultiple MyelomaLeukemia, Large Granular LymphocyticWaldenstrom Macroglobulinemia

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphomaLymphadenopathyMyelodysplastic-Myeloproliferative DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHemorrhagic DisordersNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesEye NeoplasmsNeoplasms by SiteHypergammaglobulinemiaBlood Protein DisordersParaproteinemiasLymphoma, B-CellBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms, Plasma CellAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesLeukemia, T-Cell

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ramesh Ramanathan

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

August 1, 2001

Primary Completion

January 1, 2005

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

US(1)