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Germ Cell TumorsPhase 2TICENCT00864318

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

A Phase 2 study testing Paclitaxel, Ifosfamide and Carboplatine in people with Germ Cell Tumors, run by Institut Claudius Regaud at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Germ Cell Tumors
What is being tested?
Paclitaxel, Ifosfamide and Carboplatine
How many people
101 participants
Where
12 sitesFrance
Study dates
13 Mar 2009to 5 Oct 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Centre Paul Papin

    Angers, 49933

  • Hopital St André

    Bordeaux, 33075

  • Institut Bergonié

    Bordeaux, 33076

  • CHU

    Clermont-Ferrand, 63003

  • Centre Léon Bérard

    Lyon, 69373

  • Institut Paoli Calmette

    Marseille, 13273

  • Institut Val d'aurelle

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice, 06050

  • Hopital TENON

    Paris, 75970

  • CHU

    Strasbourg, 67091

  • Institut Claudius Regaud

    Toulouse, 31052

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

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.

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.

Being tested
Paclitaxel, Ifosfamide, Carboplatine, Etoposide, cytapheresis + transfusion of autologous peripheral blood stem cells
Keywords
refractory, germ cell tumors, relapse, bad prognosis, Refractory germ cell tumors with relapse and bad prognosis
Medical subject headings
Neoplasms, Germ Cell and Embryonal, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxol

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

  • IfosfamideDrug

    Also called Holoxan

    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

  • CarboplatineDrug

    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

  • EtoposideDrug

    Also called VP16

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

  • cytapheresis + transfusion of autologous peripheral blood stem cellsProcedure or surgery

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (6)

  1. Progression free survival

    Measured: 8 years

  2. Time to progression

    Measured: 8 years

  3. Toxicity

    Measured: 6 months

  4. To find a predictive value for Cystatin C as a biomarker of renal function to avoid next to follow plasmatic concentrations to adapt Carboplatine dose in TICE protocol.

    Measured: 4 years

  5. Etoposide pharmacokinetics (in particular inter-individual variability of Etoposide plasmatic concentrations AUC in such patients

    Measured: 4 years

  6. Genetic polymorphisms involved in response and safety treatments

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2009 (estimated)
  2. Study start13 Mar 2009
  3. Primary completion5 Oct 2020
  4. Study completion5 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00864318
Sponsor's protocol ID
08 GENH 06
Acronym
TICE
Status last verified
Apr 2026
First submitted
16 Mar 2009
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Chevreau C, Massard C, Flechon A, Delva R, Gravis G, Lotz JP, Bay JO, Gross-Goupil M, Fizazi K, Mourey L, Paci A, Guitton J, Thomas F, Lelievre B, Ciccolini J, Moeung S, Gallois Y, Olivier P, Culine S, Filleron T, Chatelut E. Multicentric phase II trial of TI-CE high-dose chemotherapy with therapeutic drug monitoring of carboplatin in patients with relapsed advanced germ cell tumors. Cancer Med. 2021 Apr;10(7):2250-2258. doi: 10.1002/cam4.3687. Epub 2021 Mar 5.

    PubMed 33675184

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Ifosfamide and Carboplatine in people with Germ Cell Tumors, run by Institut Claudius Regaud at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate(by chemotherapy or chemotherapy + surgery), pathological complete response rate. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00864318, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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