Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	RTOG-S-0132 ACRIN-6665, RTOG-DEV-1055, ECOG-RTOG-R0132, RTOG-0132, NCT00028002

Objectives

1. Determine the progression-free survival of patients with primary or recurrent potentially resectable malignant gastrointestinal stromal tumor treated with neoadjuvant and adjuvant imatinib mesylate.
2. Determine the objective response rate of patients treated with this drug.
3. Determine the safety of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed malignant gastrointestinal stromal tumor
  • Potentially resectable primary disease

    OR

  • Potentially resectable recurrent disease
    • Local or intra-abdominal/pelvic metastatic disease



• Documented c-kit (CD117) expression by immunohistochemical analysis of either initial core specimen or, if recurrent disease, from original tumor block



• Primary disease must be visceral, intra-abdominal, or pelvic in origin



• At least 1 unidimensionally measurable lesion
  • At least 5 cm for primary disease
  • At least 2 cm for recurrent disease



• At least 1 viable core biopsy tumor specimen obtained within 8 weeks before registration

Prior/Concurrent Therapy:

Biologic therapy:

• At least 28 days since prior biologic therapy
• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy:

• At least 28 days since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 28 days since prior radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 28 days since prior investigational drugs
• At least 28 days since prior imatinib mesylate
• No concurrent therapeutic doses of warfarin
• Concurrent low-molecular weight heparin or mini-dose warfarin (1 mg per day) prophylaxis is allowed

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT/AST no greater than 2.5 times ULN
• No uncontrolled chronic liver disease

Renal:

• Creatinine no greater than 1.5 times ULN
• No uncontrolled chronic renal disease

Cardiovascular:

• No New York Heart Association class III or IV cardiac disease

Other:

• Must be able to lie still in the PET scanner for approximately 1-2 hours
• No uncontrollable hyperglycemia
• No medical or psychological condition that would preclude study participation
• No severe or uncontrolled medical disease
• No active uncontrolled infection
• No known or suspected hypersensitivity to any component of the study drug
• Any prior malignancy is allowed provided patient remains disease free from that malignancy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 3 months after study participation

Expected Enrollment

A total of 63 patients will be accrued for this study within 2 years.

Outcomes

Biological effects of imatinib mesylate
Rate of disease recurrence at 2 years
Rates of objective response (complete, partial, and stable)
Major toxicity (i.e., grade ≥ 3)
Correlation of glucose transported expression and positron emission tomography (PET) interpretations
Tumor changes observed on PET and correlation with size changes observed on conventional cross-sectional imaging
Diagnostic accuracy of PET to predict disease recurrence

Outline

Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Eisenberg BL, Harris J, Blanke CD, et al.: Phase II trial of neoadjuvant/adjuvant imatinib mesylate (IM) for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumor (GIST): early results of RTOG 0132/ACRIN 6665. J Surg Oncol 99 (1): 42-7, 2009.[PUBMED Abstract]

Van den Abbeele AD, Gatsonis C, de Vries DJ, et al.: ACRIN 6665/RTOG 0132 phase II trial of neoadjuvant imatinib mesylate (IM) for primary and recurrent operable malignant GIST: imaging findings and correlation with genotype and GLUT4 expression. [Abstract] J Clin Oncol 27 (Suppl 15): A-10552, 2009.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Burton Eisenberg, MD, Protocol chair		Ph: 603-653-3613; 800-639-6918

American College of Radiology Imaging Network

Annick Van den Abbeele, MD, Protocol chair		Ph: 617-632-2595; 866-790-4500

Eastern Cooperative Oncology Group

Margaret von Mehren, MD, Protocol chair		Ph: 215-728-3545; 888-369-2427

Registry Information
Official Title		A Phase II Trial of Neoadjuvant/Adjuvant STI-571 (Gleevec NSC #716051) for Primary and Recurrent Operable Malignant GIST Expressing the KIT Receptor Tyrosine Kinase (CD117)
Trial Start Date		2002-02-28
Trial Completion Date		2009-01-28
Registered in ClinicalTrials.gov		NCT00028002
Date Submitted to PDQ		2001-10-22
Information Last Verified		2009-01-28
NCI Grant/Contract Number		CA21661

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