Status:
COMPLETED
Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors
Lead Sponsor:
Medical Research Council
Conditions:
Extragonadal Germ Cell Tumor
Teratoma
Eligibility:
MALE
16+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, vincristine, bleomycin, carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the ...
Detailed Description
OBJECTIVES: Primary * Compare the response rate in patients with poor-prognosis extracranial nonseminoma germ cell tumors treated with intensive induction chemotherapy comprising cisplatin, vincrist...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Nonseminoma germ cell tumor of any extracranial primary site diagnosed by 1 of the following methods:
- Histologic confirmation
- Alpha-fetoprotein (AFP) \> 1,000 ng/mL or human chorionic gonadotropin (hCG) \> 5,000 IU/L with appropriate clinical picture in a man \< 45 years of age
- Poor prognosis features as defined by ≥ 1 of the following:
- AFP \> 10,000 ng/mL
- hCG \> 50,000 IU/L
- Lactic dehydrogenase \> 10 times normal
- Nonpulmonary visceral metastases
- Mediastinal primary site
- PATIENT CHARACTERISTICS:
- Male
- WHO performance status 0-3
- Glomerular filtration rate \> 50 mL/min
- Less than 50 mL/min eligible if due to obstructive neuropathy that can be relieved by stenting or nephrostomy
- No comorbid condition that would prevent treatment
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy except low-dose chemotherapy to stabilize disease before study therapy
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00301782
Start Date
June 1 2005
End Date
June 1 2010
Last Update
August 26 2013
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
2
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
3
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
4
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN