Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis

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Brief Title

Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis

Official Title

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.

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 consists in two Paclitaxel and Ifosfamide intensification cycles followed by three
      Carboplatine and Etoposide high dose cycles. The point is the individual Carboplatine
      adjustment to take into account inter-individual patients variability.

      This adaptation allow to control each patient plasmatic exposition to avoid both inacceptable
      toxicities (such as ear toxicity) and a low exposition losing then the benefit of this high
      dose protocol.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Progression free survival

Condition

Germ Cell Tumors

Intervention

Paclitaxel


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

101

Start Date

March 13, 2009

Completion Date

October 5, 2020

Primary Completion Date

October 5, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christine CHEVREAU, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00864318

Organization ID

08 GENH 06


Responsible Party

Sponsor

Study Sponsor

Institut Claudius Regaud


Study Sponsor

Christine CHEVREAU, MD, Principal Investigator, Institut Claudius Regaud


Verification Date

January 2021