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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Radiation Therapy Oncology Group
National Cancer Institute (NCI)
American College of Radiology Imaging Network
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028002
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Drug: imatinib mesylate
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase II

MedlinePlus related topics:   Cancer   

Drug Information available for:   Imatinib    Imatinib mesylate    Tyrosine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
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)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Biological effects of imatinib mesylate [ Designated as safety issue: No ]
  • Rate of disease recurrence at 2 years [ Designated as safety issue: No ]
  • Rates of objective response (complete, partial, and stable) [ Designated as safety issue: No ]
  • Major toxicity (i.e., grade ≥ 3) [ Designated as safety issue: Yes ]
  • Correlation of glucose transported expression and positron emission tomography (PET) interpretations [ Designated as safety issue: No ]
  • Tumor changes observed on PET and correlation with size changes observed on conventional cross-sectional imaging [ Designated as safety issue: No ]
  • Diagnostic accuracy of PET to predict disease recurrence [ Designated as safety issue: No ]

Estimated Enrollment:   63
Study Start Date:   February 2002

Detailed Description:

OBJECTIVES:

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

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.

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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

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

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028002

Locations
United States, Massachusetts
Brigham and Women's Hospital    
      Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute    
      Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center    
      Boston, Massachusetts, United States, 02114
United States, New York
Roswell Park Cancer Institute    
      Buffalo, New York, United States, 14263-0001
United States, Oregon
Cancer Institute at Oregon Health and Science University    
      Portland, Oregon, United States, 97239-3098
Providence Cancer Center at Providence Portland Medical Center    
      Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Fox Chase Cancer Center    
      Philadelphia, Pennsylvania, United States, 19111-2497

Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
American College of Radiology Imaging Network
Eastern Cooperative Oncology Group

Investigators
Study Chair:     Burton L. Eisenberg, MD     Norris Cotton Cancer Center    
Study Chair:     Annick D. Van den Abbeele, MD     Dana-Farber Cancer Institute    
Study Chair:     Margaret von Mehren, MD     Fox Chase Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000069111, RTOG-S-0132, ACRIN-6665, RTOG-DEV-1055, ECOG-RTOG-R0132
First Received:   December 7, 2001
Last Updated:   October 25, 2008
ClinicalTrials.gov Identifier:   NCT00028002
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
gastrointestinal stromal tumor  

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 December 03, 2008




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