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Sponsored by: |
Cambridge University Hospitals NHS Foundation Trust |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00453232 |
RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell tumors.
Condition | Intervention | Phase |
---|---|---|
Extragonadal Germ Cell Tumor Teratoma Testicular Germ Cell Tumor |
Biological: bleomycin Biological: pegfilgrastim Drug: cisplatin Drug: etoposide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor |
Estimated Enrollment: | 20 |
Study Start Date: | August 2004 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, pilot study.
Patients receive etoposide IV on days 1-3, cisplatin IV on days 1 and 2, and bleomycin IV over 2 hours on days 2, 6, and 10. Patients also receive pegfilgrastim subcutaneously on day 4. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients must fulfill all of the following criteria for 1 of the following diagnoses:
Nonseminoma germ cell tumor (intermediate risk)
Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria:
Seminoma (intermediate prognosis)
Surveillance relapse
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 2QQ | |
Contact: Michael Williams, MD 44-122-321-7020 michael.williams@addenbrookes.nhs.uk | |
Churchill Hospital | Recruiting |
Oxford, England, United Kingdom, OX3 7LJ | |
Contact: Andrew Protheroe, MD 44-1865-226-185 | |
Leeds Cancer Centre at St. James's University Hospital | Recruiting |
Leeds, England, United Kingdom, LS9 7TF | |
Contact: John Chester 44-113-243-3144 | |
Northern Centre for Cancer Treatment at Newcastle General Hospital | Recruiting |
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
Contact: Rhona McMenemin 44-191-219-4200 | |
Saint Bartholomew's Hospital | Recruiting |
London, England, United Kingdom, EC1A 7BE | |
Contact: Jonathan Shamash, MD, FRCP 44-207-601-7221 jonathan.shamash@bartsandthelondon.nhs.uk | |
United Kingdom, Scotland | |
Beatson West of Scotland Cancer Centre | Recruiting |
Glasgow, Scotland, United Kingdom, G11 6NT | |
Contact: Jeff White, MD 44-141-211-6364 jeff.white@northglasgow.scot.nhs.uk | |
Edinburgh Cancer Centre at Western General Hospital | Recruiting |
Edinburgh, Scotland, United Kingdom, EH4 2XU | |
Contact: Grahame Howard, MD 44-131-537-3270 |
Study Chair: | Michael Williams, MD | Cambridge University Hospitals NHS Foundation Trust |
Study ID Numbers: | CDR0000537042, CRCA-CCTC-ACCELERATED-BEP, EUDRACT-2004-000847-79, EU-20713 |
Study First Received: | March 27, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00453232 |
Health Authority: | Unspecified |
stage III malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor testicular choriocarcinoma and seminoma testicular embryonal carcinoma and seminoma testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and teratoma testicular choriocarcinoma testicular choriocarcinoma and yolk sac tumor testicular embryonal carcinoma and teratoma with seminoma testicular embryonal carcinoma and teratoma testicular embryonal carcinoma and yolk sac tumor with seminoma testicular embryonal carcinoma and yolk sac tumor testicular embryonal carcinoma |
testicular seminoma testicular yolk sac tumor testicular yolk sac tumor and teratoma with seminoma testicular yolk sac tumor and teratoma recurrent extragonadal non-seminomatous germ cell tumor recurrent extragonadal seminoma stage IV extragonadal non-seminomatous germ cell tumor stage IV extragonadal seminoma adult teratoma testicular immature teratoma testicular mature teratoma recurrent extragonadal germ cell tumor |
Choriocarcinoma Seminoma Nonseminomatous germ cell tumor Testicular Neoplasms Etoposide phosphate Bleomycin Recurrence |
Carcinoma Cisplatin Neoplasms, Germ Cell and Embryonal Testicular cancer Teratoma Etoposide Extragonadal Germ Cell Tumor |
Neoplasms Neoplasms by Histologic Type |