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Gastrointestinal Stromal TumorsPhase 2NCT00500188

Preoperative and Postoperative Imatinib Mesylate Study in Patients With c-Kit Positive GIST

A Phase 2 study testing Imatinib Mesylate (Gleevec) in people with Gastrointestinal Stromal Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary objectives 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Gastrointestinal Stromal Tumors
What is being tested?
Imatinib Mesylate (Gleevec)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
Jul 2003to Jul 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Prospective, Randomized, Phase II Study of Preoperative Plus Postoperative Imatinib Mesylate (Gleevec, Formerly STI-571) in Patients With Primary, Recurrent, or Metastatic Resectable, Kit-Expressing, Gastrointestinal Stromal Tumor (GIST)

Primary objectives

  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. 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.
Read more

Secondary objectives

  1. 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.
  2. To assess the safety and tolerability of Gleevec given to patients with GI stromal tumors 3, 5, or 7 days preoperatively and continued postoperatively.
Read the detailed description

Imatinib mesylate is a drug that may help to kill gastrointestinal stromal tumor cells.

Around 3 weeks before your scheduled surgery, you will have a PET scan, a CT scan and two to three tablespoons of blood will be collected. These are imaging tests and are being done to check on the status of the disease. These tests will be repeated the day before your scheduled surgery. If your doctor feels it is necessary, you will have a chest x-ray and 2 to 3 tablespoons of blood will be collected for routine tests. Women who are able to have children must have a negative blood pregnancy test.

Before treatment, you will also have a biopsy procedure of the tumor performed. This biopsy is being done to study the effect of imatinib mesylate on the tumor cells. The tissue that is collected during the biopsy procedure will be compared to the tumor that is taken out at the time of surgery.

You will be randomly assigned (as in the toss of a coin) to one of three groups. One group will begin taking imatinib mesylate two times a day by mouth starting 7 days before surgery. The second group will start taking imatinib mesylate 5 days before surgery. Participants in the third group will begin taking imatinib mesylate 3 days before surgery. After your surgery, the removed tumor will be studied and compared to the tissue collected before surgery to see what effect (if any) imatinib mesylate had on the tumor. All patients will then continue imatinib mesylate for 2 years after surgery.

You will take imatinib mesylate two times a day for 2 years.

If you develop any side effects to the study drug, treatment may be temporarily stopped or the dose of the drug changed until the symptoms are gone. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.

You will be seen by a physician regularly after surgery. Two to three tablespoons of blood will be collected once a month for routine tests, and a you will have a CT scan done every 3 months. These tests will help us determine if your cancer has come back.

THIS IS AN INVESTIGATIONAL STUDY. Imatinib mesylate is FDA approved and is commercially available. Up to 48 participants will take part in this study. All will be enrolled at M. D. Anderson.

Being tested
Imatinib Mesylate (Gleevec)
Keywords
Gastrointestinal Stromal Tumors, GIST, Kit expression, Resectable, Imatinib Mesylate, Gleevec, STI-571, Imatinib, NSC-716051
Medical subject headings
Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imatinib Mesylate (Gleevec)Drug

    Also called Gleevec, STI-571, Imatinib, NSC-716051

    300 mg orally twice daily

Study groups in NCT00500188
Study groupRoleWhat they receive
7 DaysExperimentalImatinib Mesylate 300 mg orally twice daily starting 7 days before surgery.
Receives: Drug: Imatinib Mesylate (Gleevec)
5 DaysExperimentalImatinib Mesylate 300 mg orally twice daily starting 5 days before surgery.
Receives: Drug: Imatinib Mesylate (Gleevec)
3 DaysExperimentalImatinib Mesylate 300 mg orally twice daily starting 3 days before surgery.
Receives: Drug: Imatinib Mesylate (Gleevec)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2007 (estimated)
  2. Study startJul 2003
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00500188
Sponsor's protocol ID
ID03-0023
Status last verified
Aug 2011
First submitted
10 Jul 2007
Last updated
8 Aug 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imatinib Mesylate (Gleevec) in people with Gastrointestinal Stromal Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) time (time frame: Baseline start of therapy to 2 years postoperative Gleevec or disease progression.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00500188.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2011.

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