Status:
COMPLETED
Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Germ Cell Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Not randomized, multicentric, national phase II trial estimating the efficacy of an intensification protocol in patients with refractory germ cell tumors with relapse and bad prognosis. Treatment con...
Eligibility Criteria
Inclusion
- Germ cell tumors whatever histology (TGNS or séminoma : TGS ) whose origin is gonadic, extra-gonadic, retro-peritoneal or primitive mediastinal
- Age \>= 18 years old
- Histologically confirmed germ cell tumor (TGS) or biomarkers rate allowing to diagnose germ cell tumor without histology (TGNS)
- Relapse or progression with bad prognosis in 1st treatment line : One of these criteria valid point 4 :
- progression after incomplete clinical response (Stable disease) to a Cisplatin basis chemotherapy; biomarker progression 4 weeks following the last chemotherapy cycle administration; progression during the first treatment line without obtention of at least stable disease; primitive mediastinal origin in first relapse.
- TGNS or TGS in relapse after 2 treatment lines
- Disease progression ( previous points 4 or 5) documented by :
- tumors biomarkers increase (AFP and/or HCG) if no, a biopsy is needed to confirm presence of tumors active cells
- ECOG Performance status 0-2
- Biological Function :
- Neutrophils \>= 1500/mm3, Platelets \>= 150.000/mm3 ; normal creatinine (or clearance \>= 50 ml/mn) ; SGOT, SGPT \<= 2,5N (or 5N if hepatic metastases), Bilirubin \< 1,5N
- Cardiac Functions (FEV \>= 50%), Respiratory Functions , neurological Functions compatibles with high dose chemotherapy administration
- Absence of previous intensification
- Patient Information and Informed consent signature
- HIV and B and C hepatitis negative serologies
- Negative pregnancy test for women with reproductive potential and adequate contraception before study entry
- Patient affiliated to social security system
Exclusion
- Patients whose diagnosis of relapse was not confirmed by an anatomopathological examination or by an increase of tumors markers
- Primitive encephalic germ cell tumors
- Germ cell tumors in relapse with favorable factors of treatment response to conventional chemotherapy (RC sustainable after Cisplatin): prior cRC or incomplete clinical response but with normalization of markers and testicular origin
- Growing Teratoma lesions
- Patients with HIV infection, hepatitis B and C
- Patients with symptomatic brain metastases despite appropriate corticosteroid treatment
- Associated pathology may prevent the patient to receive treatment, creatinine clearance ≤ 50 mL / min (calculated by Cockcroft-Gault)
- FEV \<50%
- History of cancer (except basal cell epithelioma skin cancer) in the 3 years preceding the entry into the trial
- Patient already included in another clinical trial involving an experimental molecule
- Pregnant or breast feeding women
- Persons without liberty or under guardianship,
- Geographical, social or psychological conditions that do not permit compliance with protocol
Key Trial Info
Start Date :
March 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2020
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00864318
Start Date
March 13 2009
End Date
October 5 2020
Last Update
January 12 2021
Active Locations (12)
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1
Centre Paul Papin
Angers, France, 49933
2
Hopital St André
Bordeaux, France, 33075
3
Institut Bergonié
Bordeaux, France, 33076
4
CHU
Clermont-Ferrand, France, 63003