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Dose Intensification Phase II Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis. TICE Protocol : Paclitaxel and Ifosfamide Followed by Carboplatine and Etoposide Intensification With Individual Carboplatine Dose Adjustment.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Germ Cell Tumors

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Trial Information

Dose Intensification Phase II Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis. TICE Protocol : Paclitaxel and Ifosfamide Followed by Carboplatine and Etoposide Intensification With Individual Carboplatine Dose Adjustment.


Inclusion Criteria:



1. Germ cell tumors whatever histology (TGNS or séminoma : TGS ) whose origin is
gonadic, extra-gonadic, retro-peritoneal or primitive mediastinal

2. Age >= 18 years old

3. Histologically confirmed germ cell tumor (TGS) or biomarkers rate allowing to
diagnose germ cell tumor without histology (TGNS)

4. 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.

5. TGNS or TGS in relapse after 2 treatment lines

6. 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

7. ECOG Performance status 0-2

8. 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

9. Cardiac Functions (FEV >= 50%), Respiratory Functions , neurological Functions
compatibles with high dose chemotherapy administration

10. Absence of previous intensification

11. Patient Information and Informed consent signature

12. HIV and B and C hepatitis negative serologies

13. Negative pregnancy test for women with reproductive potential and adequate
contraception before study entry

14. Patient affiliated to social security system

Exclusion Criteria:

1. Patients whose diagnosis of relapse was not confirmed by an anatomopathological
examination or by an increase of tumors markers

2. Primitive encephalic germ cell tumors

3. 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

4. Growing Teratoma lesions

5. Patients with HIV infection, hepatitis B and C

6. Patients with symptomatic brain metastases despite appropriate corticosteroid
treatment

7. Associated pathology may prevent the patient to receive treatment, creatinine
clearance ≤ 50 mL / min (calculated by Cockcroft-Gault)

8. FEV <50%

9. History of cancer (except basal cell epithelioma skin cancer) in the 3 years
preceding the entry into the trial

10. Patient already included in another clinical trial involving an experimental molecule

11. Pregnant or breast feeding women

12. Persons without liberty or under guardianship,

13. Geographical, social or psychological conditions that do not permit compliance with
protocol

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate(by chemotherapy or chemotherapy + surgery), pathological complete response rate.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Christine CHEVREAU, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

08 GENH 06

NCT ID:

NCT00864318

Start Date:

March 2009

Completion Date:

March 2018

Related Keywords:

  • Germ Cell Tumors
  • refractory
  • germ cell tumors
  • relapse
  • bad prognosis
  • Refractory germ cell tumors with relapse and bad prognosis
  • Neoplasms, Germ Cell and Embryonal

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