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Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer Clinical research trials and Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer. Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer clinical trial. Human subjects often get the best healthcare available for their Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer  Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer
Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer
For Condition: Testicular Cancer,ovarian germ cell tumor
Status: Completed
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, refractory, or recurrent stage II or stage III testicular cancer or stage II or stage III ovarian cancer following cisplatin-based chemotherapy.
Details: OBJECTIVES: - Determine the activity of imatinib mesylate in patients with progressive, refractory, or recurrent pure testicular seminoma or ovarian germ cell dysgerminoma after cisplatin-based chemotherapy. - Determine the toxicity of this drug in this patient population. - Determine KIT expression and identify mutations in the c-kit gene in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial response or stable disease with normalization of human chorionic gonadotropin may undergo surgical resection of residual lesions at each tumor status assessment. If residual viable germ cell tumor is present in the resected specimen, patients may resume imatinib mesylate. If no viable germ cell tumor is present in the resected specimen, then no further therapy is administered. Patients are followed every 3 months for 1 year and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 32-38 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed pure testicular seminoma or ovarian germ cell dysgerminoma - Histologic documentation of metastatic/recurrent disease not required - Alpha-fetoprotein level must be normal, unless abnormal level is explained by other conditions and approved by the study chair - Clinical stage II or III - Progressive, refractory, or recurrent disease, meeting at least 1 of the following criteria: - Measurable progressive disease - Biopsy-proven residual disease - Persistently elevated or rising B-human chorionic gonadotropin (HCG) titers, defined as at least 2 values above the upper limit of normal (ULN) - Cisplatin-refractory disease without option of potentially curative therapy, meeting 1 of the following criteria: - Failed high-dose chemotherapy with peripheral blood stem cell transplantation (PBSCT) or autologous bone marrow transplantation (AuBMT) - Ineligible for or refused PBSCT or AuBMT - Unlikely to achieve long-term benefit from PBSCT or AuBMT - Current evidence of metastatic disease - Unidimensionally measurable target lesions - At least 20 mm by conventional techniques (e.g., physical examination for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung) OR - At least 10 mm by spiral CT scan or MRI - If measurable disease is confined to a solitary lesion, then its neoplastic nature must be confirmed by histology - Ultrasound may not be used to measure tumor lesions that are not easily accessible clinically OR - Non-measurable/non-target lesions, with HCG at least ULN, including the following: - Bone lesions - Pleural or pericardial effusions - Ascites - CNS lesions - Leptomeningeal disease - Irradiated lesions, unless progression documented after radiotherapy PATIENT CHARACTERISTICS: Age - 15 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL (transfusion allowed) Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT/SGPT no greater than 2.5 times ULN Renal - Creatinine no greater than 1.5 times ULN Other - No other severe and/or uncontrolled concurrent medical illness - 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 - See Disease Characteristics Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy - Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) allowed - No concurrent palliative radiotherapy Surgery - Not specified Other - No concurrent grapefruit juice - No concurrent warfarin for therapeutic anticoagulation (concurrent mini-dose warfarin [1 mg orally per day] as prophylaxis allowed)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristopherRyan, Study Chair, University of Chicago Cancer Research Center
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
NorthEast Oncology Associates
Concord, North Carolina, 28025
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
New York Weill Cornell Cancer Center at Cornell University
New York City, New York, 10021
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Saint Anthony Medical Center
Rockford, Illinois, 61108
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
McGill University
Montreal, Quebec, H2W 1S6
Canada
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, 33401
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22902
United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
Elmhurst Hospital Center
Elmhurst, New York, 11373
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
United States
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
St. Mary's Medical Center
Huntington, West Virginia, 25701
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Additional Information:
Study ID Numbers: CDR0000069487; CLB-90105
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042952
Other Ovarian Germ Cell Tumor Studies:
1. Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
2. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer
3. Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer
4. Beclomethasone in Treating Patients With Graft-Versus-Host Disease of the Esophagus, Stomach, Small Intestine, or Colon
5. Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors
Related Studies:
Other ovarian germ cell tumor Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer
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