NCT00500188

Brief Summary

Primary objectives

  1. 1.To determine whether induction of apoptosis or inhibition of angiogenesis are involved in the antitumor activity of (Gleevec, Formerly STI-571) in patients with gastrointestinal stromal tumors (GIST) as assessed by Positron Emission Tomography (PET) scanning.
  2. 2.To determine whether dynamic computed tomography (CT), PET scan, molecular and histopathologic responses in GIST tumors from patients treated with Gleevec predict Disease-Free Survival (DFS) time.
  3. 3.To determine the disease free survival of patients with resectable or partially resectable gastrointestinal stromal tumors treated with Gleevec preoperatively and continued for 2 years after resection of disease.
  4. 4.To assess the safety and tolerability of Gleevec given to patients with GI stromal tumors 3, 5, or 7 days preoperatively and continued postoperatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2003

Longer than P75 for phase_2

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

July 1, 2003

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 8, 2011

Status Verified

August 1, 2011

Enrollment Period

8 years

First QC Date

July 10, 2007

Last Update Submit

August 4, 2011

Conditions

Gastrointestinal Stromal Tumors

Keywords

Gastrointestinal Stromal TumorsGISTKit expressionResectableImatinib MesylateGleevecSTI-571ImatinibNSC-716051

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival (DFS) time

    Effect of drug imatinib mesylate on gastrointestinal stromal tumors (GIST) by disease-free survival (DFS) time, measured from the start of Gleevec therapy, among the three arms to disease progression or 2 years postoperative therapy, measured in months.

    Baseline start of therapy to 2 years postoperative Gleevec or disease progression.

Study Arms (3)

7 Days

EXPERIMENTAL

Imatinib Mesylate 300 mg orally twice daily starting 7 days before surgery.

Drug: Imatinib Mesylate (Gleevec)

5 Days

EXPERIMENTAL

Imatinib Mesylate 300 mg orally twice daily starting 5 days before surgery.

Drug: Imatinib Mesylate (Gleevec)

3 Days

EXPERIMENTAL

Imatinib Mesylate 300 mg orally twice daily starting 3 days before surgery.

Drug: Imatinib Mesylate (Gleevec)

Interventions

Imatinib Mesylate (Gleevec)DRUG

300 mg orally twice daily

Also known as: Gleevec, STI-571, Imatinib, NSC-716051
3 Days5 Days7 Days

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent.
  • Patients must have a histologically proven diagnosis of primary, locally advanced and/or metastatic GIST for which complete or partial resection is planned by a MDACC sarcoma surgeon.
  • Patients must have immunohistochemical documentation of kit expression in the tumor using the DAKO A4502 or other acceptable antibody.
  • Patients must have a least one lesion greater than 1 cm that can be accurately measured in one dimension by plain radiograph, CT or magnetic resonance imaging (MRI).
  • Patients must have normal organ and marrow function (White blood count-WBC greater than or equal to 3,000/ul, Absolute neutrophil count (ANC) greater than or equal to 1500/ul, platelets greater than or equal to 100,00/ul, total bilirubin less than or equal to 1.5 \* Upper Limits of Normal (ULN), aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) less than or equal to 2.5 \* ULN, serum creatinine less than or equal to 1.5 \* ULN).
  • Patients must have a serum glucose \< 200 mg/dl prior to PET scan. Patients must be able to lie flat and still for the PET scan.
  • Patients may not have any uncontrolled medical or psychiatric conditions that would make the patient unable to tolerate therapy. Patients with uncontrolled medical conditions or psychiatric conditions may have informed consent granted by a legal guardian or surrogate decision maker.
  • Patients may not have any prior malignancy in the past 5 years other than non-melanoma skin cancer, cervical cancer in situ, or any other malignancy that is not currently clinically significant.
  • Zubrod performance status of 0 - 3.
  • May not have metastases outside of the peritoneal cavity.
  • If patients have any signs or symptoms of metastases, the appropriate workup should occur prior to enrollment (eg, CT of the head for a patient with central nervous system (CNS) symptoms).
  • Patients may not have had chemotherapy, radiotherapy, biological therapy or any investigational drugs 3 weeks prior to the study.
  • Women should have a negative pregnancy test within 7 days of study opening.
  • Patients must agree to use an effective contraceptive method.

You may not qualify if:

  • Prior treatment using Gleevec.
  • Patients with Class III or Class IV New York Heart Association congestive heart failure.
  • Pregnant or nursing women.
  • Patients taking therapeutic doses of Coumadin for anticoagulation. Coumadin may be taken but dose should be less than or equal to 1 mg po per day. Patients MAY take a low molecular weight heparin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jonathan Trent, MD, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 12, 2007

Study Start

July 1, 2003

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 8, 2011

Record last verified: 2011-08

Locations

US(1)