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Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

Primary Purpose

Gastrointestinal Stromal Tumor

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
imatinib mesylate
conventional surgery
neoadjuvant therapy
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumor focused on measuring gastrointestinal stromal tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed gastrointestinal stromal tumor Locally advanced disease Potentially resectable disease* No tumor that can be completely resected (R0) with sufficient margins NOTE: *Multivisceral resection may be necessary Tumor must stain positive for c-Kit (CD117) or platelet-derived growth factor receptor-alpha (PDGFRA) by immunohistochemistry At least 1 site of measurable disease No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-3 Life expectancy Not specified Hematopoietic Platelet count > 100,000/mm^3 Absolute neutrophil count > 1,500/mm^3 Hepatic AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic metastases are present) Bilirubin < 1.5 times ULN No chronic active hepatitis No cirrhosis No other chronic liver disease Renal Creatinine < 1.5 times ULN No chronic renal disease Cardiovascular No New York Heart Association class III-IV cardiac disease No congestive heart failure No myocardial infarction within the past 6 months Immunology No active uncontrolled infection No known HIV positivity Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment Must be medically fit to undergo surgery No other primary malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or a primary malignancy that is not currently clinically significant and does not require active intervention No gastrointestinal obstruction or major bleeding episode requiring immediate surgical intervention No uncontrolled diabetes No other severe or uncontrolled medical disease No significant history of noncompliance to medical regimens PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent anticancer biologic agents Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing No concurrent anticancer chemotherapy Endocrine therapy No concurrent systemic corticosteroid therapy unless approved by the study sponsor Radiotherapy More than 4 weeks since prior radiotherapy No prior radiotherapy to ≥ 25% of bone marrow Surgery More than 2 weeks since prior major surgery except tumor biopsy Other More than 4 weeks since prior investigational drugs unless disease is rapidly progressing No other concurrent anticancer therapy No other concurrent investigational agents No concurrent warfarin for therapeutic anticoagulation Concurrent low molecular weight heparin (e.g., enoxaparin sodium) or heparin for therapeutic anticoagulation allowed Concurrent mini-dose warfarin (e.g.,1 mg/day) for prophylaxis of central venous catheter thrombosis allowed

Sites / Locations

  • Allgemeines Krankenhaus - Universitatskliniken
  • Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
  • Universitaetsklinikum Bonn
  • Medizinische Universitaetsklinik I at the University of Cologne
  • University Medical Center Hamburg - Eppendorf
  • Klinikum der Universitaet Muenchen - Grosshadern Campus
  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen
  • Southwest German Cancer Center at Eberhard-Karls-University
  • Dr. Horst-Schmidt-Kliniken

Outcomes

Primary Outcome Measures

Overall tumor response (complete response, partial response, stable disease, and progression of disease)

Secondary Outcome Measures

Time to progression of disease
Overall survival

Full Information

First Posted
June 2, 2005
Last Updated
March 7, 2012
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00112632
Brief Title
Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor
Official Title
Open-Label Trial of Neoadjuvant Imatinib Mesylate (Glivec) in Patients With Locally Advanced Malignant Gastrointestinal Stromal Tumors (GIST) Expressing c-Kit or Platelet-Derived Growth Factor Receptor-alpha
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Technical University of Munich

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced gastrointestinal stromal tumor.
Detailed Description
OBJECTIVES: Primary Determine radiographic objective response rates in patients with locally advanced gastrointestinal stromal tumor treated with neoadjuvant imatinib mesylate. Determine histological response in patients treated with this drug. Secondary Determine R0-resectability and organ-preserving resectability in these patients after treatment with this drug. Correlate radiographic imaging and metabolic imaging with histological response in patients treated with this drug. Determine the safety and tolerability of this drug in these patients. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive oral imatinib mesylate once or twice daily for 4-6 months in the absence of disease progression or unacceptable toxicity. Within 2-3 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection. After completion of study treatment, patients are followed at 4 weeks, 6 months, and then at 1 year. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor
Keywords
gastrointestinal stromal tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Primary Outcome Measure Information:
Title
Overall tumor response (complete response, partial response, stable disease, and progression of disease)
Secondary Outcome Measure Information:
Title
Time to progression of disease
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed gastrointestinal stromal tumor Locally advanced disease Potentially resectable disease* No tumor that can be completely resected (R0) with sufficient margins NOTE: *Multivisceral resection may be necessary Tumor must stain positive for c-Kit (CD117) or platelet-derived growth factor receptor-alpha (PDGFRA) by immunohistochemistry At least 1 site of measurable disease No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-3 Life expectancy Not specified Hematopoietic Platelet count > 100,000/mm^3 Absolute neutrophil count > 1,500/mm^3 Hepatic AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if hepatic metastases are present) Bilirubin < 1.5 times ULN No chronic active hepatitis No cirrhosis No other chronic liver disease Renal Creatinine < 1.5 times ULN No chronic renal disease Cardiovascular No New York Heart Association class III-IV cardiac disease No congestive heart failure No myocardial infarction within the past 6 months Immunology No active uncontrolled infection No known HIV positivity Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment Must be medically fit to undergo surgery No other primary malignancy within the past 5 years except basal cell skin cancer, carcinoma in situ of the cervix, or a primary malignancy that is not currently clinically significant and does not require active intervention No gastrointestinal obstruction or major bleeding episode requiring immediate surgical intervention No uncontrolled diabetes No other severe or uncontrolled medical disease No significant history of noncompliance to medical regimens PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent anticancer biologic agents Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) unless disease is rapidly progressing No concurrent anticancer chemotherapy Endocrine therapy No concurrent systemic corticosteroid therapy unless approved by the study sponsor Radiotherapy More than 4 weeks since prior radiotherapy No prior radiotherapy to ≥ 25% of bone marrow Surgery More than 2 weeks since prior major surgery except tumor biopsy Other More than 4 weeks since prior investigational drugs unless disease is rapidly progressing No other concurrent anticancer therapy No other concurrent investigational agents No concurrent warfarin for therapeutic anticoagulation Concurrent low molecular weight heparin (e.g., enoxaparin sodium) or heparin for therapeutic anticoagulation allowed Concurrent mini-dose warfarin (e.g.,1 mg/day) for prophylaxis of central venous catheter thrombosis allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Licht, MD
Organizational Affiliation
Technical University of Munich
Official's Role
Study Chair
Facility Information:
Facility Name
Allgemeines Krankenhaus - Universitatskliniken
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
City
Berlin
ZIP/Postal Code
D-13122
Country
Germany
Facility Name
Universitaetsklinikum Bonn
City
Bonn
ZIP/Postal Code
D-53105
Country
Germany
Facility Name
Medizinische Universitaetsklinik I at the University of Cologne
City
Cologne
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
University Medical Center Hamburg - Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen - Grosshadern Campus
City
Munich
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81675
Country
Germany
Facility Name
Southwest German Cancer Center at Eberhard-Karls-University
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Dr. Horst-Schmidt-Kliniken
City
Wiesbaden
ZIP/Postal Code
D-65199
Country
Germany

12. IPD Sharing Statement

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Imatinib Mesylate in Treating Patients With Locally Advanced Gastrointestinal Stromal Tumor

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