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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)

Phase 2
18 Years
Not Enrolling
Gastrointestinal Stromal Tumor

Thank you

Trial Information

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)


I. Determine the progression-free survival of patients with primary or recurrent potentially
resectable malignant gastrointestinal stromal tumor treated with neoadjuvant and adjuvant
imatinib mesylate.

II. Determine the objective response rate of patients treated with this drug. III. Determine
the safety of this drug in these patients.


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.

Inclusion Criteria:

- Histologically confirmed malignant gastrointestinal stromal tumor

- Potentially resectable primary disease

- 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

- Performance status - Zubrod 0-2

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- 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

- Creatinine no greater than 1.5 times ULN

- No uncontrolled chronic renal disease

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

- 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

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for 3 months
after study participation

- At least 28 days since prior biologic therapy

- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

- At least 28 days since prior chemotherapy

- At least 28 days since prior radiotherapy

- See Disease Characteristics

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in biological markers of imatinib mesylate, including c-kit and tyrosine

Outcome Time Frame:

From baseline to 2 years

Safety Issue:


Principal Investigator

Burton Eisenberg

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiation Therapy Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

February 2002

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Tumors



Radiation Therapy Oncology Group Philadelphia, Pennsylvania  19107