Not Signed In -
Imatinib |
Gleevec; imatinib mesylate |
Clinical Trial: Neoadjuvant and Adjuvant Imatinib Mesylate in Treating Patients With Primary or Recurrent Malignant Gastrointestinal Stromal Tumor
This study is currently recruiting patients.
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 malignantgastrointestinal stromal tumor.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| gastrointestinal stromal tumor | Drug: imatinib mesylate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: enzyme inhibitor therapy Procedure: neoadjuvant therapy Procedure: protein tyrosine kinase inhibitor therapy Procedure: surgery | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Digestive Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Neoadjuvant and Adjuvant Imatinib Mesylate in Patients With Primary or Recurrent Potentially Resectable Malignant Gastrointestinal Stromal Tumor
Further Study Details:
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 above, Genders Eligible for Study: Both
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
- Required to have 3 core tissue biopsies performed at least 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:
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
Location and Contact Information
Alabama
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3300, United States; Recruiting
Carla I. Falkson, MD 205-975-2691 cfalkson@uab.edu
Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, 85259-5404, United States; Recruiting
Tom Robert Fitch, MD 480-301-9875
Foundation for Cancer Research and Education, Phoenix, Arizona, 85013, United States; Recruiting
David G. Brachman, MD, FACRO 602-274-4484
California
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
Clinical Trials Office - New Patient Services 800-826-4673 becomingapatient@coh.org
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, 94305-5216, United States; Recruiting
Harlan A. Pinto, MD 650-725-9057
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, 94304-1290, United States; Recruiting
Harlan A. Pinto, MD 650-493-5000 ext. 4948
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
Stephen Scott Grubbs, MD 302-623-4100
District of Columbia
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, 20060, United States; Recruiting
Lucile L. Adams-Campbell, PhD 202-806-7697
Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, 33612-9497, United States; Recruiting
Julie A. Kish, MD, FACP 813-972-8432
Veterans Affairs Medical Center - Gainesville, Gainesville, Florida, 32608-1197, United States; Recruiting
Dean Latain McCarley, MD 352-374-6016
Veterans Affairs Medical Center - Miami, Miami, Florida, 33125, United States; Recruiting
Niramol Savaraj, MD 305-575-3143 nsavaraj@med.miami.edu
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Julie A. Kish, MD, FACP 813-972-2000
Georgia
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, 30033, United States; Recruiting
Maria Jose Amarante Ribeiro, MD 404-728-7680 maria.ribeiro@med.va.gov
Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322, United States; Recruiting
William Costin Wood, MD 404-778-5180
Illinois
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, MD 217-383-4083 kendrith.rowland@carle.com
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
James L. Wade, MD 217-876-6617 jlwade3@sbcglobal.net
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
Gershon Y. Locker, MD, FACP 847-570-2518 glocker@enh.org
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
John W. Kugler, MD 309-243-3605
Northwest Community Hospital, Arlington Heights, Illinois, 60005, United States; Recruiting
Arnold M. Herskovic, MD 847-618-6576 arnoldh134@aol.com
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, 60611, United States; Recruiting
Al Bowen Benson, MD, FACP 312-695-1382
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, 60611-4494, United States; Recruiting
Timothy M. Kuzel, MD 312-469-3748
Indiana
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting
Rafat H. Ansari, MD, FACP 574-284-7977
Indiana University Cancer Center, Indianapolis, Indiana, 46202-5289, United States; Recruiting
Patrick J. Loehrer, MD 317-278-7418
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, 46202, United States; Recruiting
Patrick J. Loehrer, MD 317-554-0000
Iowa
Burgess Health Center, Onawa, Iowa, 51040, United States; Recruiting
James A. Mailliard, MD 712-423-2311
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, 52403-1206, United States; Recruiting
Martin Wiesenfeld, MD 319-363-8303
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, 50309-1016, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-244-7586
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, 50316-2301, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-663-5612
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, 50309, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-241-4245
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, 50314, United States; Recruiting
Roscoe F. Morton, MD, FACP 515-247-3121
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-268-5784
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-685-2221
Louisiana
CCOP - Ochsner, New Orleans, Louisiana, 70121, United States; Recruiting
Carl G. Kardinal, MD 504-842-3910
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Jill Gilbert, MD 504-568-5613 jgilbe@lsuhsc.edu
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Michael Benjamin Atkins, MD 617-667-1930
Cancer Center at Tufts - New England Medical Center, Boston, Massachusetts, 02111, United States; Recruiting
John K. Erban, MD 617-636-5147 jerban@tufts-nemc.org
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
Annick D. Van den Abbeele, MD 617-632-3223
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
Anthony F. Shields, MD, PhD 313-745-6258 shieldsa@karmanos.org
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
Raymond Sterling Lord, MD 269-373-7488 rlord@wmcc.org
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237 beekmanl@trinity-health.org
West Michigan Cancer Center, Kalamazoo, Michigan, 49007, United States; Recruiting
Contact Person 616-373-7488
Minnesota
CCOP - Duluth, Duluth, Minnesota, 55805, United States; Recruiting
Robert J. Dalton, MD 218-786-8364 rdalton@smdc.org
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn, MD 952-993-1517 patrick.flynn@usoncology.com
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905-0001, United States; Recruiting
Michael G. Haddock, MD 507-284-2511
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
George L. Adams, MD 612-625-2410 adams002@umn.edu
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, 55417-2399, United States; Recruiting
Markus Gapany, MD, FACS 612-725-2000 ext. 3459 gapan001@maroon.tc.umn.edu
Nebraska
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106, United States; Recruiting
James A. Mailliard, MD 402-280-4364 jamailliard@mrcc.cc
Midlands Cancer Center at Midlands Community Hospital, Papillion, Nebraska, 68128-4157, United States; Recruiting
James A. Mailliard, MD 402-593-3000
Veterans Affairs Medical Center - Omaha, Omaha, Nebraska, 68105, United States; Recruiting
James A. Mailliard, MD 402-280-5274
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
John Allan Ellerton, MD, CM 702-384-0013 k.vanwagenen@sncrf.org
New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
Camilo E. Fadul, MD 603-650-6312 Camilo.e.fadul@dartmouth.edu
New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting
Joseph Aisner, MD 732-235-7401 aisnerjo@umdnj.edu
CCOP - Northern New Jersey, Hackensack, New Jersey, 07601, United States; Recruiting
Richard J. Rosenbluth, MD 201-996-5917
Monmouth Medical Center, Long Branch, New Jersey, 07740-6395, United States; Recruiting
Sang Sim 732-923-6575
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, 07018, United States; Recruiting
Basil S. Kasimis, MD, DSc 973-676-1000 ext. 7095 Basil.Kasimis@med.va.gov
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Cynthia K. Cathcart, MD 505-272-5688
New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States; Recruiting
Joseph A. Sparano, MD 718-904-2555 jsparano@montefiore.org
MBCCOP-Our Lady of Mercy Cancer Center, Bronx, New York, 10466, United States; Recruiting
Peter H. Wiernik, MD 718-920-9900 pwiernik@olmhs.org
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Howard S. Hochster, MD 212-731-5100 howard.hochster@med.nyu.edu
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
Michael R. Kuettel, MD, PhD 716-845-1562
Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York, 11209, United States; Recruiting
Andrea Nadine Wiesel Leaf, MD 718-630-3691
Veterans Affairs Medical Center - New York, New York, New York, 10010, United States; Recruiting
Howard S. Hochster, MD 212-652-1912 howard.hochster@med.nyu.edu
North Dakota
CCOP - Merit Care Hospital, Fargo, North Dakota, 58122, United States; Recruiting
Preston D. Steen, MD 701-234-6298 prestonsteen@meritcare.com
Ohio
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
J. Philip Kuebler, MD, PhD 614-488-2118
CCOP - Toledo Community Hospital, Toledo, Ohio, 43623-3456, United States; Recruiting
Paul L. Schaefer, MD 419-843-6147
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195, United States; Recruiting
Robert Dreicer, MD, FACP 216-445-4623
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Recruiting
Edward G. Mansour, MD 216-778-4394 emansour@metrohealth.org
Oklahoma
CCOP - Oklahoma, Tulsa, Oklahoma, 74136, United States; Recruiting
James B. Lockhart, MD 918-491-5878
Oregon
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97239-3098, United States; Recruiting
John Michael Holland, MD 503-494-8759
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Keith S. Lanier, MD 503-216-6260
Pennsylvania
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Daniel G. Haller, MD 215-662-6318
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
Albert M. Bernath, MD 570-271-6466
CCOP - MainLine Health, Wynnewood, Pennsylvania, 19096, United States; Recruiting
Paul B. Gilman, MD 610-645-2494
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States; Recruiting
Benjamin Movsas, MD 215-728-5304 b_movsas@fccc.edu
Hahnemann University Hospital, Philadelphia, Pennsylvania, 19102-1192, United States; Recruiting
Pamela Ann Crilley, DO 215-762-8547
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15236, United States; Recruiting
John Munn Kirkwood, MD 412-692-4724
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States; Recruiting
Witold Boleslaw Rybka, MD, FRCPC 717-531-1050 wrybka@med.hmc.psu.edu
Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania, 15240, United States; Recruiting
Timothy Carlos, MD 412-688-6248 timothy.carlos@med.va.gov
South Dakota
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, 57104, United States; Recruiting
Loren K. Tschetter, MD 605-328-8044 tidemanb@siouxvalley.org
Tennessee
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, 37232-6307, United States; Recruiting
David Horton Johnson, MD 615-343-9454 david.h.johnson@vanderbilt.edu
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville, Tennessee, 37212-2637, United States; Recruiting
Kenneth R. Hande, MD 615-327-4751
Texas
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org
Utah
Cottonwood Hospital Medical Center, Murray, Utah, 84107, United States; Recruiting
Contact Person 801-314-5300
Dixie Regional Medical Center, Saint George, Utah, 84770, United States; Recruiting
Ray S. Richards, MD 801-688-4175
LDS Hospital, Salt Lake City, Utah, 84143, United States; Recruiting
William T. Sause, MD 801-408-1146 ldwsause@ihc.com
McKay-Dee Hospital Center, Ogden, Utah, 84403, United States; Recruiting
Contact Person 801-627-2800
Utah Valley Regional Medical Center - Provo, Provo, Utah, 84604, United States; Recruiting
Tarlton Jay Blair, MD 801-373-7850 ext. 2480
Wisconsin
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, 54449, United States; Recruiting
Tarit Kumar Banerjee, MD, FACP 715-387-5511
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, 54301, United States; Recruiting
Gerald K. Bayer, MD 920-433-8889
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, 53226-3596, United States; Recruiting
David H. Vesole, MD, PhD 414-805-4626 dvesole@bmt.mcw.edu
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792-0001, United States; Recruiting
James A. Stewart, MD 608-265-8131 stewart@biostat.wisc.edu
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, 53705, United States; Recruiting
Mark R. Albertini, MD 608-262-7017
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, 53295, United States; Recruiting
Mohammed A. Raheem, MD 414-384-2000
Australia, New South Wales
Westmead Hospital, Westmead, New South Wales, 2145, Australia; Recruiting
Richard Kefford, MD, PhD 61-2-9845-6033
Peru
Instituto de Enfermedades Neoplasicas, Lima, 34, Peru; Recruiting
Carlos Santiago Vallejos-Sologuren, MD 51-14-499-137 postmaster@inen.sld.pe
Puerto Rico
MBCCOP - San Juan, San Juan, 00921-3201, Puerto Rico; Recruiting
Luis Baez-Diaz, MD 787-641-3693 sjccop@prtc.net
San Juan City Hospital, San Juan, 00936-7344, Puerto Rico; Recruiting
Luis Baez-Diaz, MD 787-641-3693 sjccop@prtc.net
Veterans Affairs Medical Center - San Juan, San Juan, 00927-5800, Puerto Rico; Recruiting
Luis Baez-Diaz, MD 787-641-7582 sjccop@prtc.net
South Africa
Pretoria Academic Hospital, Pretoria, 0001, South Africa; Recruiting
Coenraad Frederick Slabber, MD 27-12-354-1054
Study chairs or principal investigators
Burton L. Eisenberg, MD, Study Chair, Norris Cotton Cancer Center
Annick D. Van den Abbeele, MD, Study Chair, Dana-Farber/Harvard Cancer Center
Margaret von Mehren, MD, Study Chair, Fox Chase Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000069111; RTOG-S-0132; ACRIN-6665; RTOG-DEV-1055; ECOG-RTOG-R0132; NCT00028002
Record last reviewed: October 2004
Last Updated: April 5, 2005
Record first received: December 7, 2001
ClinicalTrials.gov Identifier: NCT00028002
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: October 2004
Last Updated: April 5, 2005
Record first received: December 7, 2001
ClinicalTrials.gov Identifier: NCT00028002
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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