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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-13

Study Completion Date

2020-10-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Germ Cell Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Paclitaxel

200mg/m2 for 3 hours at Cycle 1 day 1 and Cycle 2 day 1 with 14 days between cycles

Intervention Type DRUG

Ifosfamide

2g/m²/day in 1 liter of G5 for 3 hours at Cycle 1 and Cycle 2 from day 2 to day 4 with 14 days between cycles

Intervention Type DRUG

Carboplatine

From cycle 3 to cycle 5 :

Carboplatine is administered with AUC = 24 mg/mL x min from Day 1 to Day 3. Day 3 Carboplatine dose is calculated taking into account real creatinine clearance defined at day 1 for each patient

Intervention Type DRUG

Etoposide

From Cycle 3 to cycle 5, 400mg/m2/day from day 1 to day 3

Intervention Type DRUG

cytapheresis + transfusion of autologous peripheral blood stem cells

Cytapheresis occured between day 11 and day 13 of the 2 first cycle (Taxol® +Holoxan®). Cytapheresis total objective is 9X106 CD34+/kg of patient weight.

At cycle 3, 4 and 5 at day 5 : Re-injection of stem cells (1/3 with minimum 2.106 CD34/kg) 48 hours after chemotherapy end

Intervention Type PROCEDURE

Other Intervention Names

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Taxol Holoxan VP16

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No