Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Maligna… (NCT00028002) | Clinical Trial Compass
CompletedPhase 2
Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor
United States63 participantsStarted 2002-03-31
Plain-language summary
Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in treating patients who are undergoing surgery for primary or recurrent malignant gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving imatinib mesylate before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 registration
* 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 allowe…