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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer Clinical research trials and Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer  Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer
Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer
For Condition: Testicular Cancer,brain metastases,bone metastases,liver metastases,Mediastinal Cancer
Status: Recruiting
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known whether chemotherapy plus peripheral stem cell transplantation is more effective than chemotherapy alone. PURPOSE: Randomizedphase III trial to compare the effectiveness of combination chemotherapy with or without peripheral stem cell transplantation in treating men who have previously untreated germ cell cancer.
Details: OBJECTIVES: - Compare the efficacy of standard cisplatin, etoposide, and ifosfamide (VIP) followed by sequential high-dose VIP and stem cell rescue versus bleomycin, etoposide, and cisplatin (BEP) in men with previously untreated poor-prognosis germ cell cancer. - Compare the acute and late toxicities of these treatment regimens in this patient population. - Compare these regimens in terms of failure-free survival, response rate, and overall survival in these patients. - Evaluate the quality of life in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, primary mediastinal germ cell tumor (yes vs no), and nonpulmonary visceral metastases (liver vs bone vs brain). Patients are randomized to one of two treatment arms. - Arm I: Patients receive etoposide IV over 1 hour followed by cisplatin IV over 1 hour on days 1-5 and bleomycin IV over 30 minutes on days 2, 8, and 15. Treatment repeats every 3 weeks for 4 courses. - Patients receive 1 course of standard dose chemotherapy consisting of etoposide IV over 1 hour followed by cisplatin IV over 1 hour and ifosfamide IV over 1 hour on days 1-5. Peripheral blood stem cells (PBSC) are harvested around day 12-15. Patients also receive daily filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until PBSC collection is complete. After day 21, patients receive high-dose chemotherapy consisting of etoposide IV over 1 hour followed by cisplatin IV over 1 hour, and ifosfamide IV over 1 hour on days -6 through -2. PBSCs are infused on day 0. Patients receive daily G-CSF subcutaneously beginning on day 1 and continuing through day 19 or until blood counts have recovered. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before chemotherapy, at 6 months, and at 2 years after treatment. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and annually thereafter. PROJECTED ACCRUAL: A total of 222 patients (111 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/50 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven germ cell cancer - Nonseminoma OR - Combined seminoma and nonseminoma - Poor prognosis (nonseminoma): - Testis/retroperitoneal primary AND - One of the following poor tumor markers - AFP greater than 10,000 iu/L - HCG greater than 50,000 iu/L - LDH greater than 10 times upper limit of normal OR - Nonpulmonary visceral metastases (i.e., liver, bone, or brain) OR - Mediastinal primary PATIENT CHARACTERISTICS: Age: - 16 to 50 Sex: - Male Performance status: - WHO 0-3 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - AST no greater than 2 times ULN Renal: - Creatinine clearance at least 60 mL/min (unless due to obstructive uropathy correctable by nephrostomy) Other: - No other malignancy except basal cell skin cancer - No neuropathy - No other serious illness or medical condition - No psychological, familial, sociological, or geographical condition that would prevent compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Concurrent radiotherapy for brain metastases allowed Surgery: - Concurrent surgery for brain metastases allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GedskeDaugaard, , Rigshospitalet
Aarhus Kommunehospital *Recruiting*
Aarhus, , DK-8000
Denmark
Recruiting Contact Person 45-8-612-5555
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Contact Person 44-113-206-4904
Hospital Donostia *Recruiting*
San Sebastian, , 20080
Spain
Recruiting Contact Person 34-943-007-147
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-71-52-6911
Hospital Clinico Universitario *Recruiting*
Zaragoza, , 50009
Spain
Recruiting Contact Person 34-3-50-418
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Contact Person 47-22-93-4000
Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff, Wales, CF4 7XL
United Kingdom
Recruiting Contact Person 44-29-2061-5888
Martin Luther Universitaet *Recruiting*
Halle (Saale), , DOH-06112
Germany
Recruiting Contact Person 49-345-5570
Hospital Clinico Universitario - Malaga *Recruiting*
Malaga, , 29010
Spain
Recruiting Contact Person 34-2-64-9483
Knappschaft Krankenhaus *Recruiting*
Bochum-Langendreer, , D-44892
Germany
Recruiting Contact Person 49-234-2990
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-3-821-3000
Kaiser Franz Josef Hospital *Recruiting*
Vienna (Wien), , A-1100
Austria
Recruiting Contact Person 43-1-601-9152
Klinikum der Universitaet Regensburg *Recruiting*
Regensburg, , D-93053
Germany
Recruiting Contact Person 49-941-7047-7110
Johannes Gutenberg University *Recruiting*
Mainz, , D-55101
Germany
Recruiting Contact Person 49-61-31-1771
Universitaets-Krankenhaus Eppendorf *Recruiting*
Hamburg, , D-20246
Germany
Recruiting Contact Person 49-40-428-030
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-439-1911
Staedtisches Klinikum Dessau *Recruiting*
Dessau, , D-06822
Germany
Recruiting Contact Person 49-340-501-1214
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet *Recruiting*
Greifswald, , D-17487
Germany
Recruiting Contact Person 49-3834-77-951
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-24-361-1111
Institut Jules Bordet *Recruiting*
Brussels (Bruxelles), , 1000
Belgium
Recruiting Contact Person 32-2-541-3111
Ospedale di Circolo e Fondazione Macchi *Recruiting*
Varese, , 21100
Italy
Recruiting Contact Person 39-332-278-111
Hospital de la Santa Cruz I Sant Pau *Recruiting*
Barcelona, , 08025
Spain
Recruiting Contact Person 34-3-473-133
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-33-2211
Inselspital, Bern *Recruiting*
Bern, , CH-3010
Switzerland
Recruiting Contact Person 41-31-632-2111
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology *Recruiting*
Warsaw, , 02 781
Poland
Recruiting Contact Person 48-22-644-50-24
Institut Catala D'Oncologia *Recruiting*
Barcelona, , 08907
Spain
Recruiting Contact Person 34-3-357-652
Hospital Universitario LA FE *Recruiting*
Valencia, , 46009
Spain
Recruiting Contact Person 34-96-386-2700
Klinikum Rechts Der Isar - Technische Universitaet Muenchen *Recruiting*
Munich (Muenchen), , D-81675
Germany
Recruiting Contact Person 49-89-4140
Universitaetsklinikum Essen *Recruiting*
ESSEN, , D-45122
Germany
Recruiting Contact Person 49-201-72-311
University Hospital - Rotterdam Dijkzigt *Recruiting*
Rotterdam, , 3000 CA
Netherlands
Recruiting Contact Person 31-10-463-9222
Universitaetsklinikum Bonn *Recruiting*
Bonn, , D-53105
Germany
Recruiting Contact Person 49-228-280-3816
National Cancer Institute - Bratislava *Recruiting*
Bratislava, , 833 10
Slovakia
Recruiting Contact Person 421-2-5937-8111
St. Johannes Hospital - Medical Klinik II *Recruiting*
Duisburg, , D-47166
Germany
Recruiting Contact Person 49-203-546-2480
Academisch Ziekenhuis Maastricht *Recruiting*
Maastricht, , 6202 AZ
Netherlands
Recruiting Contact Person 31-43-387-6543
Rigshospitalet *Recruiting*
Copenhagen, , 2100
Denmark
Recruiting Contact Person 45-3-545-4286
Additional Information:
Study ID Numbers: CDR0000067134; EORTC-30974
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003941
Other Mediastinal Cancer Studies:
1. Carmustine Implants in Treating Patients With Brain Metastases
2. Radiation Therapy With or Without Temozolomide in Treating Patients With Non-Small Cell Lung Cancer That is Metastatic to the Brain
3. Radiation Therapy in Preventing CNS Metastases in Patients With Non-Small Cell Lung Cancer
4. Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
5. Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
Related Studies:
Other Mediastinal Cancer Clinical Trials
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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer
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