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

Sponsors and Collaborators:	M.D. Anderson Cancer Center Novartis
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00500188

Purpose

Primary objectives

To determine whether induction of apoptosis or inhibition of angiogenesis are involved in the antitumor activity of Gleevec in patients with GIST as assessed by PET scanning.
To determine whether dynamic CT, PET scan, molecular and histopathologic responses in GIST tumors from patients treated with Gleevec predict DFS time.

Secondary objectives

To determine the disease free survival of patients with resectable or partially resectable GI 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.

Condition	Intervention	Phase
Gastrointestinal Stromal Tumors	Drug: Imatinib Mesylate	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy 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)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn what effect the drug imatinib mesylate has on gastrointestinal stromal tumors (GIST). [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	July 2003
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Imatinib Mesylate starting 7 days before surgery.	Drug: Imatinib Mesylate 300 mg PO Twice Daily
2: Experimental Imatinib Mesylate starting 5 days before surgery.	Drug: Imatinib Mesylate 300 mg PO Twice Daily
3: Experimental Imatinib Mesylate starting 3 days before surgery.	Drug: Imatinib Mesylate 300 mg PO Twice Daily

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

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 MRI.
Patients must have normal organ and marrow function (WBC greater than or equal to 3,000/ul, 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 x ULN, ALT or AST less than or equal to 2.5 x ULN, serum creatinine less than or equal to 1.5 x 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 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:

Prior treatment using Gleevec.
Patients with Class III or Class IV NY 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500188

Contacts

Contact: Jonathan Trent, MD, PhD

713-792-3626

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jonathan Trent, MD, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Novartis

Investigators

Principal Investigator:

Jonathan Trent, MD, PhD

U.T.M.D. Anderson Cancer Center

More Information

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Jonathan Trent, MD, PhD/Assistant Professor )
Study ID Numbers:	ID03-0023
Study First Received:	July 10, 2007
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00500188
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Gastrointestinal Stromal Tumors
GIST
Imatinib Mesylate
Gleevec
STI-571

Study placed in the following topic categories:

Imatinib
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009