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

Primary Purpose

Gastrointestinal Stromal Tumors

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Imatinib Mesylate (Gleevec)

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring Gastrointestinal Stromal Tumors, GIST, Kit expression, Resectable, Imatinib Mesylate, Gleevec, STI-571, Imatinib, NSC-716051

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

7 Days

5 Days

3 Days

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00500188

First Posted

July 10, 2007

Last Updated

August 4, 2011

Sponsor

M.D. Anderson Cancer Center

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00500188

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

July 2003 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

Novartis

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary objectives 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. 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. Secondary objectives 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. To assess the safety and tolerability of Gleevec given to patients with GI stromal tumors 3, 5, or 7 days preoperatively and continued postoperatively.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Stromal Tumors

Keywords

Gastrointestinal Stromal Tumors, GIST, Kit expression, Resectable, Imatinib Mesylate, Gleevec, STI-571, Imatinib, NSC-716051

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

7 Days

Arm Type

Experimental

Arm Description

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

Arm Title

5 Days

Arm Type

Experimental

Arm Description

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

Arm Title

3 Days

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Imatinib Mesylate (Gleevec)

Other Intervention Name(s)

Gleevec, STI-571, Imatinib, NSC-716051

Intervention Description

300 mg orally twice daily

Primary Outcome Measure Information:

Title

Disease-free survival (DFS) time

Description

Time Frame

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Trent, MD, PhD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

The University of Texas M.D.Anderson Cancer Center

Learn more about this trial

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

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