Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor

Recruiting in Palo Alto (17 mi)

+143 other locations

Overseen by George Demetri

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

Randomized phase III trial to compare the effectiveness of two different doses of STI571 in treating patients who have metastatic or unresectable gastrointestinal stromal tumor. STI571 may interfere with the growth of tumor cells and may be an effective treatment for cancer. It is not yet known which dose of STI571 is more effective in treating gastrointestinal stromal tumors.

Research Team

George Demetri

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

Inclusion Criteria

The primary must be of visceral or intra-abdominal origin

All patients must have immunohistochemical documentation of KIT (CD117) expression by tumor documented by DAKO antibody staining for suggested methodology) Material must be submitted to the CALGB Pathology Coordinating Center for pathology review; it is strongly recommended that snap-frozen tissue biopsy and sera be stored for future submission whenever possible

Patient must have measurable or non-measurable disease by conventional scan imaging (CT or MRI) or physical examination; tests used to assess disease must have been performed within 28 days prior to registration; if a target lesion has been previously embolized or irradiated, there must be objective evidence of progression to be considered for response assessment

Treatment Details

Interventions

• Imatinib Mesylate (Tyrosine Kinase Inhibitor)

Participant Groups

Group I: Arm II (imatinib mesylate) Experimental Treatment 1 Intervention

Patients receive oral imatinib mesylate twice daily.

Group II: Arm I (imatinib mesylate) Experimental Treatment 1 Intervention

Patients receive oral imatinib mesylate once daily.

Imatinib Mesylate is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Imatinib Mesylate for:

• Chronic Myelogenous Leukemia
• Acute Lymphoblastic Leukemia
• Gastrointestinal Stromal Tumor
• Hypereosinophilic Syndrome
• Dermatofibrosarcoma Protuberans
• Systemic Mastocytosis

Approved in Japan as Imatinib Mesylate for:

• Chronic Myelogenous Leukemia
• Acute Lymphoblastic Leukemia
• Gastrointestinal Stromal Tumor
• Hypereosinophilic Syndrome
• Dermatofibrosarcoma Protuberans
• Systemic Mastocytosis

Approved in China as Imatinib Mesylate for:

• Chronic Myelogenous Leukemia
• Acute Lymphoblastic Leukemia
• Gastrointestinal Stromal Tumor
• Hypereosinophilic Syndrome
• Dermatofibrosarcoma Protuberans
• Systemic Mastocytosis

Approved in Switzerland as Imatinib Mesylate for:

• Chronic Myelogenous Leukemia
• Acute Lymphoblastic Leukemia
• Gastrointestinal Stromal Tumor
• Hypereosinophilic Syndrome
• Dermatofibrosarcoma Protuberans
• Systemic Mastocytosis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Chicago Comprehensive Cancer Center Chicago, IL

University of Minnesota Medical Center-Fairview Minneapolis, MN

Our Lady Bellefonte Hospital Ashland, KY

Unity Hospital Fridley, MN

More Trial Locations

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14080

Patients Recruited

41,180,000+

Southwest Oncology Group

Collaborator

Trials

389

Patients Recruited

260,000+

Eastern Cooperative Oncology Group

Collaborator

Trials

272

Patients Recruited

153,000+

SWOG Cancer Research Network

Collaborator

Trials

403

Patients Recruited

267,000+

NCIC Clinical Trials Group

Collaborator

Trials

190

Patients Recruited

145,000+