Status:
COMPLETED
High-dose Chemotherapy With Autologous Stem Cell Transplantation in Poor Prognosis Germ-cell Tumors: TAXIF II
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Amgen
Conditions:
Testicular Neoplasms
Eligibility:
MALE
18-65 years
Phase:
PHASE2
Brief Summary
High-dose chemotherapy (HD-CT) is able to circumvent platinum-resistance of resistant/refractory germ-cell tumors (GCTs), but expectancy of cure remains low. New strategies are needed with new drugs a...
Detailed Description
The treatment is designed for relapsed poor prognosis patients with testicular or extra-gonadal GCTs previously treated with cisplatin-containing regimens. Poor prognosis patients are defined as eith...
Eligibility Criteria
Inclusion
- Eligibility requirements includes the following criteria:
- Age \>18 years and \< 65
- Performance status \< 3
- Histologically or biologically documented GCTs
- Testicular, abdominal, or mediastinal tumors
- Measurable or evaluable disease
- Life expectancy \> 3 months
- Normal cardiac, liver, and renal function tests
- Absence of infection
- HIV negative test
- Signed informed consent
- All patients had to have been previously treated with at least one line of a cisplatin-containing regimen and were included if they were refractory after one or two line(s) of cisplatin-based CT, or had relapsed after two lines of a cisplatin-based CT
Exclusion
- Fireproof diseases (progress unless month with regard to the last cycle of chemotherapy or in the course of chemotherapy)
- Relapses after complete answer obtained by surgery ( sCR )
- Neuropathy of superior rank or = II - renal Function (Office) superior creatinine or = 125 mmol/l and/or clearance of the creatinine subordinate or = II 60ml / mn
- Antecedents of congestive even compensated cardiac insufficiency
- Hurts of growing teratoma that is measurable hurts increasing by size (cutting) in the absence of rise of marker pens
- Extensive chemotherapy with support of haematopoietic stem cells. NB: A previous preventive irradiation under diaphragmatitis for a seminoma stage I (dose from 24 to 30 Gy in classic spreading) does not establish one against formal indication. However, an estimation clarifies capacities of the haematopoietic marrow is recommended with observation of the evolution of the NFP in the course of chemotherapy and quantification of cells CD 34 + in the peripheral blood. It's the same of the case where a chemotherapy by carboplatine was realized
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00231582
Start Date
September 1 2004
End Date
January 1 2010
Last Update
February 25 2011
Active Locations (1)
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1
Hôpital TENON, Service d'Oncologie Médicale
Paris, France, 75020