A Phase 2 interventional study of Paclitaxel and Ifosfamide in Germ Cell Tumors, sponsored by Institut Claudius Regaud. Completed at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Institut Claudius Regaud · Phase 2, Interventional, and Treatment
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.
291 studies on the registry are indexed under Neoplasms, Germ Cell and Embryonal; 51 are open to participants now.
This study's enrollment of 101 is above the median of 37 across 211 interventional studies indexed under Neoplasms, Germ Cell and Embryonal.
Browse Neoplasms, Germ Cell and Embryonal studies →Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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
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
Exclusion Criteria:
200mg/m2 for 3 hours at Cycle 1 day 1 and Cycle 2 day 1 with 14 days between cycles
Also known as: Taxol
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
Also known as: Holoxan
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
From Cycle 3 to cycle 5, 400mg/m2/day from day 1 to day 3
Also known as: VP16
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
Complete response rate(by chemotherapy or chemotherapy + surgery), pathological complete response rate.
Time frame: 6 months
Progression free survival
Time frame: 8 years
Time to progression
Time frame: 8 years
Toxicity
Time frame: 6 months
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.
Time frame: 4 years
Etoposide pharmacokinetics (in particular inter-individual variability of Etoposide plasmatic concentrations AUC in such patients
Time frame: 4 years
Genetic polymorphisms involved in response and safety treatments
Time frame: 4 years
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Neoplasms, Germ Cell and Embryonal→
Institut Claudius Regaud