Clinical trial • Phase III • Oncology
IFOSFAMIDE for Germ cell tumor (relapsed or refractory)
Phase III trial of IFOSFAMIDE for Germ cell tumor (relapsed or refractory).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Germ cell tumor (relapsed or refractory)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 05-08-2024
- First CTIS Authorization Date
- 27-08-2024
Trial design
Randomised, randomized comparison of conventional-dose chemotherapy tip (paclitaxel + ifosfamide + cisplatin) versus high-dose chemotherapy ti-ce (mobilizing paclitaxel + ifosfamide followed by high-dose carboplatin and etoposide with autologous stem cell transplant). dose and schedule details not specified in the provided record.-controlled Phase III trial in Netherlands, Belgium, Denmark and others.
- Randomised
- Yes
- Comparator
- Randomized comparison of conventional-dose chemotherapy TIP (paclitaxel + ifosfamide + cisplatin) versus high-dose chemotherapy TI-CE (mobilizing paclitaxel + ifosfamide followed by high-dose carboplatin and etoposide with autologous stem cell transplant). Dose and schedule details not specified in the provided record.
- Target Sample Size
- 219
Stratification factors
- Modified IPFSG risk category
Eligibility
Recruits 219 paediatric patients.
- Vulnerable Population
- Written informed consent is required according to ICH/GCP and national/local regulations. Age-specific subject information and consent forms are provided (including forms for patients 14-15 years old, forms for patients 16-17, and forms for parents or legal representatives). Country-specific/local language ICFs and addenda are included in the dossier; assent/parental consent processes are supported by dedicated documents for minors.
Inclusion criteria
- {"criterion_text":"- Confirmation of GCT histology (both seminoma and nonseminoma) on pathologic review at the center of enrollment. Tumor may have originated in any primary site.\n- Negative Serology (antibody test) for the following infectious diseases: a. Human Immunodeficiency Virus (HIV) type 1 and 2; b. Human T-cell Leukemia Virus (HTLV) type 1 and 2 (mandatory in US but optional in Canada and Europe); c. Hepatitis B surface antigen; d. Hepatitis C antibody\n- Reproductive risk: patient must not father a baby while in this study. The treatment could affect sperm or semen. Therefore, patient and his partner must use an appropriate and effective contraceptive method during the study period and for approximately 6 months after taking the last dose of study drug. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently.\n- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.\n- Must have evidence of progressive or recurrent GCT (measurable or non-measurable) following one line of cisplatin-based chemotherapy, defined as meeting at least one of the following criteria: * Tumor biopsy of new or growing or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after macroscopically complete resection of viable GCT is not allowed). In the event of an incomplete gross resection where viable GCT is found, patients will be considered eligible for the study. * Consecutive elevated serum tumor markers (HCG or AFP) that are increasing. Increase of an elevated LDH alone does not constitute progressive disease. * Development of new or enlarging lesions in the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to increase.\n- Must have received 3-6 cycles of cisplatin-based chemotherapy as part of first-line (initial) chemotherapy. Prior POMBACE, CBOP-BEP, or GAMEC are allowed.\n- No more than one prior line of chemotherapy for GCT (other than the 1 cycle of salvage chemotherapy).\n- Must have adequate recovery from prior surgery (e.g., healed scar, resumption of diet, etc.).\n- Age ≥ 14 years (≥ 15 years in France, ≥ 16 years in Ireland, ≥ 18 years in Germany, Denmark, Switzerland, the Netherlands, Slovenia and Italy)\n- ECOG Performance Status 0 to 2\n- Male gender\n- Required Initial Laboratory Values: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3; Platelet Count ≥ 100,000/mm3; Calc. Creatinine Clearance ≥ 50 mL/min; Bilirubin ≤ 2.0 x upper limits of normal (ULN); AST/ALT ≤ 2.5 x upper limits of normal (ULN)"}
Exclusion criteria
- {"criterion_text":"- Prior treatment with high-dose chemotherapy (defined as treatment utilizing stem cell rescue).\n- Contraindications to the use of paclitaxel, ifosfamide, cisplatine, carboplatine and etoposide as per summary of product characteristics (SPC).\n- Prior treatment with TIP with the exception when given as a bridge to treatment on protocol for patients with rapidly progressive disease who cannot wait to complete the eligibility screening process. Only one cycle is allowed.\n- Concurrent treatment with other cytotoxic drugs or targeted therapies.\n- Radiation therapy (other than to the brain) within 14 days of day 1 of protocol chemotherapy except radiation to brain metastases, which must be completed 7 days prior to start of chemotherapy.\n- Previous chemotherapy within 16 days prior to enrollment except for bleomycin which cannot have been given within 5 days prior to enrollment.\n- Concurrent malignancy other than non-melanoma skin cancer, superficial noninvasive (pTa or pTis) TCC of the bladder, contralateral GCT, or intratubular germ cell neoplasia. Patients with a prior malignancy, but at least 2 years since any evidence of disease are allowed.\n- Late relapse with completely surgically resectable disease. Patients with late relapses (defined as relapse ≥ 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable are not eligible. Patients with late relapses who have unresectable disease are eligible.\n- Large (≥ 2 cm) hemorrhagic or symptomatic brain metastases until local treatment has been administered (radiation therapy or surgery). Treatment may begin ≥ 7 days after completion of local treatment. Patients with small (< 2 cm) and asymptomatic brain metastases are allowed and may be treated with radiation therapy and/or surgery concurrently with Arm A or cycles 1 and 2 of Arm B if deemed medically indicated. Radiation therapy should not be given concurrently with highdose carboplatin or etoposide.\n- Secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant transformation) when it is actively part of the disease recurrence or progression."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Progression Free Survival (PFS)\n- Favorable Response Rate (FRR)\n- Treatment-related mortality\n- Toxicity","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 219
- Recruitment Window Months
- 142
- Consent Approach
- Written informed consent is required prior to registration/randomization according to ICH/GCP and national/local regulations. Age-specific information and consent/assent forms are provided (adult forms; forms for patients aged 14-15; forms for patients aged 16-17; forms for parents or legal representatives). Country-specific/local language consent documents and addenda are included in the trial documents.
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 201
Netherlands
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 27-08-2024
- Processing Time Days
- 7
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Netherlands Cancer Institute
- Department Name
- Medical Oncology
- Principal Investigator Name
- Martijn Kerst
- Principal Investigator Email
- j.kerst@nki.nl
- Contact Person Name
- Martijn Kerst
- Contact Person Email
- j.kerst@nki.nl
Belgium
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 28-08-2024
- Processing Time Days
- 8
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Institut Jules Bordet
- Department Name
- Chemotherapy
- Principal Investigator Name
- Thierry Gil
- Principal Investigator Email
- thierry.gil@hubruxelles.be
- Contact Person Name
- Thierry Gil
- Contact Person Email
- thierry.gil@hubruxelles.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 30-08-2024
- Processing Time Days
- 10
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Rigshospitalet
- Department Name
- Medical Oncology
- Principal Investigator Name
- Gedske Daugaard
- Principal Investigator Email
- kirsten.gedske.daugaard@regionh.dk
- Contact Person Name
- Gedske Daugaard
- Contact Person Email
- kirsten.gedske.daugaard@regionh.dk
France
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 03-09-2024
- Processing Time Days
- 14
- Number Of Sites
- 5
- Number Of Participants
- 35
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Hematology
- Principal Investigator Name
- Cristina Castilla Llorente
- Principal Investigator Email
- cristina.castilla-llorente@gustaveroussy.fr
- Contact Person Name
- Cristina Castilla Llorente
- Contact Person Email
- cristina.castilla-llorente@gustaveroussy.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Aude Flechon
- Principal Investigator Email
- aude.flechon@lyon.unicancer.fr
- Contact Person Name
- Aude Flechon
- Contact Person Email
- aude.flechon@lyon.unicancer.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Medical Oncology
- Principal Investigator Name
- Loic Mourey
- Principal Investigator Email
- mourey.loic@iuct-oncopole.fr
- Contact Person Name
- Loic Mourey
- Contact Person Email
- mourey.loic@iuct-oncopole.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jean-Pierre Lotz
- Principal Investigator Email
- jean-pierre.lotz@tnn.aphp.fr
- Contact Person Name
- Jean-Pierre Lotz
- Contact Person Email
- jean-pierre.lotz@tnn.aphp.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medical Oncology
- Principal Investigator Name
- Gwenelle Gravis
- Principal Investigator Email
- gravisg@ipc.unicancer.fr
- Contact Person Name
- Gwenelle Gravis
- Contact Person Email
- gravisg@ipc.unicancer.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 27-08-2024
- Processing Time Days
- 7
- Number Of Sites
- 10
- Number Of Participants
- 72
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sebastian Ochsenreither
- Principal Investigator Email
- sebastian.ochsenreither@charite.de
- Contact Person Name
- Sebastian Ochsenreither
- Contact Person Email
- sebastian.ochsenreither@charite.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Medical Oncology
- Principal Investigator Name
- Carsten Bokemeyer
- Principal Investigator Email
- c.bokemeyer@uke.de
- Contact Person Name
- Carsten Bokemeyer
- Contact Person Email
- c.bokemeyer@uke.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Internal Medicine
- Principal Investigator Name
- Miriam Kull
- Principal Investigator Email
- miriam.kull@uniklinik-ulm.de
- Contact Person Name
- Miriam Kull
- Contact Person Email
- miriam.kull@uniklinik-ulm.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Medical Oncology
- Principal Investigator Name
- Viktor Gruenwald
- Principal Investigator Email
- Viktor.Gruenwald@uk-essen.de
- Contact Person Name
- Viktor Gruenwald
- Contact Person Email
- Viktor.Gruenwald@uk-essen.de
- Site Name
- Philipps-Universitaet Marburg
- Department Name
- Internal Medicine
- Principal Investigator Name
- Andreas Burchert
- Principal Investigator Email
- Andreas.Burchert@med.uni-marburg.de
- Contact Person Name
- Andreas Burchert
- Contact Person Email
- Andreas.Burchert@med.uni-marburg.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medical Oncology
- Principal Investigator Name
- Stephan Richter
- Principal Investigator Email
- stephan.richter@uniklinikum-dresden.de
- Contact Person Name
- Stephan Richter
- Contact Person Email
- stephan.richter@uniklinikum-dresden.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Medical Oncology
- Principal Investigator Name
- Stefanie Zschaebitz
- Principal Investigator Email
- Stefanie.Zschaebitz@med.uni-heidelberg.de
- Contact Person Name
- Stefanie Zschaebitz
- Contact Person Email
- Stefanie.Zschaebitz@med.uni-heidelberg.de
- Site Name
- Klinikum Nuernberg
- Department Name
- Medical Oncology
- Principal Investigator Name
- Kerstin Schaefer-Eckart
- Principal Investigator Email
- schaefer@klinikum-nuernberg.de
- Contact Person Name
- Kerstin Schaefer-Eckart
- Contact Person Email
- schaefer@klinikum-nuernberg.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Internal Oncology
- Principal Investigator Name
- Guido Kobbe
- Principal Investigator Email
- kobbe@med.uni-duesseldorf.de
- Contact Person Name
- Guido Kobbe
- Contact Person Email
- kobbe@med.uni-duesseldorf.de
- Site Name
- Rotkreuzklinikum Muenchen gGmbH
- Department Name
- Oncology
- Principal Investigator Name
- Marcus Hentrich
- Principal Investigator Email
- Harry.Reisch@swmbrk.de
- Contact Person Name
- Marcus Hentrich
- Contact Person Email
- Harry.Reisch@swmbrk.de
Ireland
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 27-08-2024
- Processing Time Days
- 7
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- St James's Hospital
- Department Name
- Medical Oncology
- Principal Investigator Name
- Dearbhaile O'Donnell
- Principal Investigator Email
- dodonnell@stjames.ie
- Contact Person Name
- Dearbhaile O'Donnell
- Contact Person Email
- dodonnell@stjames.ie
Spain
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 09-09-2024
- Processing Time Days
- 20
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Medical Oncology
- Principal Investigator Name
- Pablo Maroto
- Principal Investigator Email
- jmaroto@santpau.cat
- Contact Person Name
- Pablo Maroto
- Contact Person Email
- jmaroto@santpau.cat
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Xavier Garcia Del Muro
- Principal Investigator Email
- garciadelmuro@iconcologia.net
- Contact Person Name
- Xavier Garcia Del Muro
- Contact Person Email
- garciadelmuro@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Enrique Gonzalez Billalabeitia
- Principal Investigator Email
- enrique.gonzalezbilla@gmail.com
- Contact Person Name
- Enrique Gonzalez Billalabeitia
- Contact Person Email
- enrique.gonzalezbilla@gmail.com
- Site Name
- Hospital General Universitario Morales Meseguer
- Department Name
- Medical Oncology
- Principal Investigator Name
- Marta Zafra Poves
- Principal Investigator Email
- martazafrap@gmail.com
- Contact Person Name
- Marta Zafra Poves
- Contact Person Email
- martazafrap@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 04-09-2024
- Processing Time Days
- 15
- Number Of Sites
- 2
- Number Of Participants
- 46
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology
- Principal Investigator Name
- Massimo Di Nicola
- Principal Investigator Email
- massimo.dinicola@istitutotumori.mi.it
- Contact Person Name
- Massimo Di Nicola
- Contact Person Email
- massimo.dinicola@istitutotumori.mi.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Medical Oncology
- Principal Investigator Name
- Paolo Pedrazzoli
- Principal Investigator Email
- p.pedrazzoli@smatteo.pv.it
- Contact Person Name
- Paolo Pedrazzoli
- Contact Person Email
- p.pedrazzoli@smatteo.pv.it
Sponsor
Primary sponsor
- Full Name
- Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Belgium
Third parties
- {"country":"Ireland","full_name":"Cancer Trials Ireland","duties_or_roles":"","organisation_type":"Patient organisation/association"}
- {"country":"United States","full_name":"The Ohio State University","duties_or_roles":"Tumor genetic analysis, pharmacogenomics","organisation_type":"Educational Institution"}
- {"country":"France","full_name":"Unicancer","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"Sample shipment, biobanking","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"OncoDrugConsult B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Philipps-Universitaet Marburg","duties_or_roles":"","organisation_type":"Educational Institution"}
- {"country":"Luxembourg","full_name":"Luxembourg Institute Of Health","duties_or_roles":"Biobanking","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- IFOSFAMIDE
- Active Substance
- IFOSFAMIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- 2
- Maximum Dose
- 6000
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- 2
- Maximum Dose
- 3600
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- 2
- Maximum Dose
- 400
- Investigational Product Name
- ETOPOSIDE
- Active Substance
- ETOPOSIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- 2
- Maximum Dose
- 3600
- Investigational Product Name
- PACLITAXEL
- Active Substance
- PACLITAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- 2
- Maximum Dose
- 1000
- Combination Treatment
- Yes
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