Status:
COMPLETED
Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Extragonadal Germ Cell Tumor
Teratoma
Eligibility:
MALE
18-40 years
Phase:
PHASE2
Brief Summary
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 divid...
Detailed Description
OBJECTIVES: Primary * Determine the feasibility of accelerated treatment comprising bleomycin, etoposide, cisplatin, and pegfilgrastim in men with metastatic germ cell tumors. * Determine the toxici...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Patients must fulfill all of the following criteria for 1 of the following diagnoses:
- Nonseminoma germ cell tumor (intermediate risk)
- Testis or retroperitoneal primary
- Abnormal markers (alpha fetoprotein \[AFP\] \> 1,000 and \< 10,000 ng/mL, human chorionic gonadotropin \[HCG\] \> 5,000 and \< 50,000 IU/L, lactate dehydrogenase \[LDH\] \> 1.5 times and \< 10 times upper limit of normal \[ULN\])
- No liver, bone, brain, or other nonpulmonary visceral metastasis
- Histologic confirmation is not required if AFP or HCG are grossly elevated
- Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria:
- Mediastinal primary
- Nonpulmonary visceral metastases
- Poor markers (AFP \> 10,000 ng/mL, HCG \> 50,000 IU/L, LDH \> 10 times ULN)
- Histologic confirmation not required if AFP or HCG are grossly elevated
- Seminoma (intermediate prognosis)
- Histological confirmation is required
- Any primary site
- Nonpulmonary visceral metastases must be present
- Normal AFP
- Any HCG
- Any LDH
- Surveillance relapse
- Must fulfill appropriate criteria above according to initial histology
- PATIENT CHARACTERISTICS:
- Neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Must have adequate renal function (creatinine clearance ≥ 60 mL/min)
- No prior malignancy except basal cell carcinoma
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00453232
Start Date
August 1 2004
End Date
January 1 2009
Last Update
August 7 2013
Active Locations (7)
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1
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
2
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
3
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
4
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom, NE4 6BE