Not Signed In -
Imatinib |
Gleevec; imatinib mesylate |
Clinical Trial: Imatinib Mesylate in Treating Patients With Locally Recurrent or Metastatic Dermatofibrosarcoma Protuberans (DFSP) or Transformed Fibrosarcomatous DFSP
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.
PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally recurrent or metastatic dermatofibrosarcoma protuberans (DFSP) or transformed fibrosarcomatous DFSP (a type of soft tissue sarcoma).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult fibrosarcoma recurrent adult soft tissue sarcoma stage III adult soft tissue sarcoma adult malignant fibrous histiocytoma stage IV adult soft tissue sarcoma | Drug: imatinib mesylate Procedure: enzyme inhibitor therapy Procedure: protein tyrosine kinase inhibitor therapy | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Soft Tissue Sarcoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Imatinib Mesylate in Patients With Locally Recurrent or Metastatic Dermatofibrosarcoma Protuberans (DFSP) or Transformed Fibrosarcomatous DFSP
Further Study Details:
OBJECTIVES:
- Determine the response rate (confirmed complete and partial response) in patients with locally recurrent or metastatic dermatofibrosarcoma protuberans (DFSP) or transformed fibrosarcomatous DFSP treated with imatinib mesylate.
- Determine the 1-year progression-free survival probability in patients treated with this drug.
- Determine the frequency and severity of toxic effects of this drug in these patients.
- Determine the presence of platelet-derived growth factor beta (PDGFB) gene rearrangements detectable by reverse transcription polymerase chain reaction and/or fluorescence in situ hybridization in patients treated with this drug.
- Correlate, preliminarily, plasma levels of this drug after 1 month of treatment with response in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with documented tumor progression and no serious side effects may continue therapy at a higher dose for another 6 courses.
Patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10 months-3.4 years.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Dermatofibrosarcoma protuberans (DFSP)
- Locally recurrent or metastatic disease OR primary disease for which complete excision with wide margin (> 1-2 cm) would result in unacceptable cosmetic disfigurement or functional impairment
- Transformed fibrosarcomatous DFSP
- Primary, locally recurrent, or metastatic disease
- Measurable disease
- No known CNS metastases
PATIENT CHARACTERISTICS: Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- WBC ≥ 2,000/mm^3
Hepatic
- SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
- Albumin ≥ 2.5 g/dL
- Bilirubin ≤ 1.5 times ULN
Renal
- Not specified
Other
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception during and for 3 months after study participation
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission
PRIOR CONCURRENT THERAPY: Biologic therapy
- More than 28 days since prior biologic therapy for DFSP
- No concurrent anticancer biologic agents
Chemotherapy
- More than 28 days since prior chemotherapy for DFSP
- No concurrent chemotherapy agents
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
- Must have evidence of progressive disease within OR measurable disease outside irradiated field
- No concurrent radiotherapy
Surgery
- At least 14 days since prior major surgery and recovered
- Biopsy of DFSP not considered major surgery
Other
- More than 28 days since prior investigational agents for DFSP
- No concurrent therapeutic doses of warfarin
- Concurrent mini-dose warfarin (1 mg per day) as prophylaxis allowed
- No other concurrent investigational agents
- No other concurrent anticancer agents
Location and Contact Information
Alabama
MBCCOP - Gulf Coast, Mobile, Alabama, 36607, United States; Recruiting
Paul O. Schwarzenberger, MD 251-544-1013
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724, United States; Recruiting
Thomas P. Miller, MD 520-626-2667
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
David Kyle King, MD, FACP 602-239-2413 david.king@baannerhealth.com
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona, 85012, United States; Recruiting
Thomas Dale Kummet, MD 602-277-5551
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States; Recruiting
Harinder S. Garewal, MD 520-629-4686
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
Laura Fulper Hutchins, MD 501-686-8511 LFHutchins@uams.edu
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas, 72205, United States; Recruiting
Bart Barlogie, MD 501-526-2873
California
CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States; Recruiting
Joseph Szumowski, MD 510-465-8570
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States; Recruiting
Ian C. Anderson, MD 707-521-3830
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
Randall F. Holcombe, MD 714-456-5153 rholcomb@uci.edu
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
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033, United States; Recruiting
Heinz-Josef Lenz, MD 323-865-3955 lenz@usc.edu
Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda, California, 92357, United States; Recruiting
Mark E. Reeves, MD, PhD 909-583-6064
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States; Recruiting
David R. Gandara, MD 925-372-2064
Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States; Recruiting
Anthony D. Elias, MD 720-848-1622 Anthony.Elias@uchsc.edu
Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States; Recruiting
Madeleine A. Kane, MD, PhD 303-399-8020 ext. 3129 madeleine.kane@med.va.gov
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
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, 33612, United States; Recruiting
Raoul R. Salup, MD 813-972-7579 raoul.salup@med.va.gov
Georgia
CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States; Recruiting
Thomas E. Seay, MD, PhD 404-851-2340
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Brian F. Issell, MD 808-586-3015 brian@crch.hawaii.edu
Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, 60153-5500, United States; Recruiting
Patrick J. Stiff, MD 708-327-3148
CCOP - Central Illinois, Decatur, Illinois, 62526, United States; Recruiting
James L. Wade, MD 217-876-6617 jlwade3@sbcglobal.net
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-569-6129
Veterans Affairs Medical Center - Hines, Hines, Illinois, 60141, United States; Recruiting
Nirmala Bhoopalam, MD 708-202-2782
Kansas
CCOP - Wichita, Wichita, Kansas, 67214-3882, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-268-5784
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, 66160-7353, United States; Recruiting
Sarah A. Taylor, MD 913-588-6029 sataylor@kumc.edu
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States; Recruiting
Shaker R. Dakhil, MD, FACP 316-685-2221
Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0084, United States; Recruiting
Michael A. Doukas, MD 859-257-3379
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40502-2236, United States; Recruiting
Michael A. Doukas, MD 859-281-4956
Louisiana
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States; Recruiting
Glenn M. Mills, MD 318-675-5970 gmills@lsuhsc.edu
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Jill Gilbert, MD 504-568-5613 jgilbe@lsuhsc.edu
Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana, 70112, United States; Recruiting
Alan M. Miller, MD, PhD 504-587-7566 amiller@tulane.edu
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States; Recruiting
German S. Beltran, MD 504-588-5482
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71101-4295, United States; Recruiting
Glenn M. Mills, MD 318-221-8411
Massachusetts
Cancer Research Center at Boston Medical Center, Boston, Massachusetts, 02118, United States; Recruiting
Douglas V. Faller, MD, PhD 617-638-4173
Michigan
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States; Recruiting
Lawrence E. Flaherty, MD 313-745-9155 flaherty@karmanos.org
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
Jeanne Archer, PhD, APN 248-551-8299 carcher@beaumon.edu
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
Kathleen Jo Yost, MD 616-391-1230
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Robert Anthony Chapman, MD 313-916-1332 rchapma1@hfhs.org
Providence Cancer Institute at Providence Hospital - Southfield, Southfield, Michigan, 48075, United States; Recruiting
Anibal Drelichman, MD, MPH, FACP 313-552-0620 adrelichman@yahoo.com
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0948, United States; Recruiting
Laurence H. Baker, DO, FACOI 734-936-3983 bakerl@umich.edu
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States; Recruiting
Lawrence E. Flaherty, MD 313-576-1000
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States; Recruiting
James Tate Thigpen, MD 601-984-5590 jthigpen@medicine.umsmed.edu
Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, 39531-2410, United States; Recruiting
Robert Woody Veith, MD 504-568-5151
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States; Recruiting
James Tate Thigpen, MD 601-362-4471
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
John Wendall Goodwin, MD 417-269-4520 jwg684@sprg.mercy.net
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States; Recruiting
Bethany G. Sleckman, MD 314-569-6573
Saint Louis University Cancer Center, Saint Louis, Missouri, 63110, United States; Recruiting
Paul J. Petruska, MD 314-268-5451 petruspj@slu.edu
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, 64128, United States; Recruiting
Sarah A. Taylor, MD 816-861-4700 ext. 491
Montana
CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States; Recruiting
Patrick W. Cobb, MD 406-259-2245
New Mexico
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States; Recruiting
Cheryl L. Willman, MD 505-272-5837
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, 87108-5138, United States; Recruiting
Cheryl L. Willman, MD 505-265-1711
New York
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
Daniel P. Petrylak, MD 212-305-1731 dpp5@columbia.edu
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
Richard I. Fisher, MD 585-275-0842 richard_fisher@urmc.rochester.edu
NYU Cancer Institute at New York University Medical Center, New York, New York, 10016, United States; Recruiting
Amy D. Tiersten, MD 212-652-1916
North Carolina
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
James N. Atkins, MD 336-777-3088
Ohio
CCOP - Columbus, Columbus, Ohio, 43206, United States; Recruiting
J. Philip Kuebler, MD, PhD 614-488-2118
CCOP - Dayton, Dayton, Ohio, 45429, United States; Recruiting
Howard M. Gross, MD 937-832-1093
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, 45267-0501, United States; Recruiting
Abdul-Rahman Jazieh, MD, MPH 513-584-3830
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-9001, United States; Recruiting
George Thomas Budd, MD 216-444-6480
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, 45220-2288, United States; Recruiting
Albert F. Muhleman, MD 513-475-6537 albert.muhleman@med.va.gov
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428-1002, United States; Recruiting
Howard M. Gross, MD 937-268-6511
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Daniel J. Culkin, MD, FACS 405-271-6900 daniel-culkin@ouhsc.edu
Oregon
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97201-3098, United States; Recruiting
Craig R. Nichols, MD 503-494-6346
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Keith S. Lanier, MD 503-216-6260
Veterans Affairs Medical Center - Portland, Portland, Oregon, 97207, United States; Recruiting
Christopher W. Ryan, MD 503-220-8262
South Carolina
CCOP - Greenville, Greenville, South Carolina, 29615, United States; Recruiting
Jeffrey Kent Giguere, MD 864-241-6251
CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States; Recruiting
James Dewitt Bearden, MD 864-560-7050
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, 29425, United States; Recruiting
Carolyn E. Reed, MD 843-792-9321 reedce@musc.edu
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, 29401-5799, United States; Recruiting
Carolyn E. Reed, MD 843-789-7804
Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital, Memphis, Tennessee, 38104, United States; Recruiting
Mohammad Jahanzeb, MD 901-722-0532
Veterans Affairs Medical Center - Memphis, Memphis, Tennessee, 38104, United States; Recruiting
Harvey B. Niell, MD 901-523-8990 ext. 5533
Texas
Brooke Army Medical Center, Fort Sam Houston, Texas, 78234-6200, United States; Recruiting
Mitchell A. Garrison, MD 210-916-3281 mitchell.garrison@cen.amedd.army.mil
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org
Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting
James E. Clarkson, MD 806-359-4673 ext. 228 jclarkson@harringtoncc.org
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4095, United States; Recruiting
Scott Michael Lippman, MD, FACP 713-745-3672
University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229-3900, United States; Recruiting
Geoffrey R. Weiss, MD 210-567-4777 weiss@uthscsa.edu
University of Texas Medical Branch, Galveston, Texas, 77555-0565, United States; Recruiting
Robert P. Whitehead, MD 409-772-1164 rpwhiteh@utmb.edu
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, 79106, United States; Recruiting
Stephen E. Wright, MD 806-359-4673 ext. 230
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78229, United States; Recruiting
Geoffrey R. Weiss, MD 210-617-5186
Veterans Affairs Medical Center - Temple, Temple, Texas, 76504, United States; Recruiting
Phalguni Mukhopadhyay, MD 254-778-4811 ext. 4809
Utah
Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112-5550, United States; Recruiting
Wolfram Samlowski, MD 801-585-0255 wolfram.samlowski@hci.utah.edu
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, 84148, United States; Recruiting
Wolfram Samlowski, MD 801-582-1565 ext. 1272
Virginia
MBCCOP - Massey Cancer Center, Richmond, Virginia, 23298-0037, United States; Recruiting
John D. Roberts, MD 804-828-0450
Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk, Virginia, 23510-1115, United States; Recruiting
Paul F. Schellhammer, MD 757-457-5182
Washington
CCOP - Northwest, Tacoma, Washington, 98405-0986, United States; Recruiting
Lauren Kenneth Colman, MD 253-403-5259 lauren.colman@multicare.org
CCOP - Virginia Mason Research Center, Seattle, Washington, 98101, United States; Recruiting
Andrew David Jacobs, MD 206-341-0446
Puget Sound Oncology Consortium, Seattle, Washington, 98109, United States; Recruiting
Saul E. Rivkin, MD 206-386-2441
Veterans Affairs Medical Center - Seattle, Seattle, Washington, 98108, United States; Recruiting
William H. Schubach, MD 206-764-2265
Study chairs or principal investigators
Scott M. Schuetze, MD, PhD, University of Michigan Comprehensive Cancer Center
Vivien H.C. Bramwell, MB, BS, PhD, FRCP, Tom Baker Cancer Centre - Calgary
George Daniel Demetri, MD, Dana-Farber/Harvard Cancer Center
Margaret von Mehren, MD, Fox Chase Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000365465; SWOG-S0345; NCT00084630
Record last reviewed: September 2004
Last Updated: April 5, 2005
Record first received: June 10, 2004
ClinicalTrials.gov Identifier: NCT00084630
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: September 2004
Last Updated: April 5, 2005
Record first received: June 10, 2004
ClinicalTrials.gov Identifier: NCT00084630
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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