Clinical trial • Phase II • Oncology
MIFAMURTIDE for High-grade osteosarcoma | High-risk osteosarcoma
Phase II trial of MIFAMURTIDE for High-grade osteosarcoma | High-risk osteosarcoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- High-grade osteosarcoma | High-risk osteosarcoma
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme | Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 13-06-2024
- First CTIS Authorization Date
- 10-07-2024
Trial design
Randomised, open-label, post-operative chemotherapy alone (standard post-operative chemotherapy; agents mentioned in the trial documentation include cisplatin, doxorubicin hydrochloride, methotrexate, ifosfamide, etoposide). specific doses/schedules for the comparator arm are not specified in the provided data.-controlled Phase II trial across 37 sites in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Post-operative chemotherapy alone (standard post-operative chemotherapy; agents mentioned in the trial documentation include CISPLATIN, DOXORUBICIN HYDROCHLORIDE, METHOTREXATE, IFOSFAMIDE, ETOPOSIDE). Specific doses/schedules for the comparator arm are not specified in the provided data.
- Target Sample Size
- 315
- Trial Duration For Participant
- 252
Eligibility
Recruits 315 paediatric patients.
- Pregnancy Exclusion
- Pregnancy or breast-feeding
- Vulnerable Population
- The trial includes minors (>2 years). Informed consent requirements: "Written informed consent from patients and/or their parents/guardians before enrolment and any study-related procedure" and "Provision of dated and signed written informed consent for the randomised trial prior to any study specific procedures, sampling and analyses." Consent from parents/guardians is required for minors; assent procedures for children are not explicitly described in the available documentation.
Inclusion criteria
- {"criterion_text":"- At diagnosis : All newly diagnosed, biopsy-proven, high-grade osteosarcoma, whatever the initial extension of the disease"}
- {"criterion_text":"- For the randomisation : Osteosarcoma classified as high risk because of at least one risk factor"}
- {"criterion_text":"- For the randomisation : Pre-operative chemotherapy"}
- {"criterion_text":"- For the randomisation : Screening laboratory values must meet the following criteria (using CTCAE v5) and should be obtained within 7 days prior to randomisation"}
- {"criterion_text":"- For the randomisation : Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 7 days prior to randomisation"}
- {"criterion_text":"- For the randomisation : Provision of dated and signed written informed consent for the randomised trial prior to any study specific procedures, sampling and analyses."}
- {"criterion_text":"- For the randomisation : Patient fit to undergo protocol treatment and follow-up"}
- {"criterion_text":"- For the randomisation : Affiliation to a social insurance regimen"}
- {"criterion_text":"- At diagnosis : Age >2 years and ≤50 years"}
- {"criterion_text":"- At diagnosis : Normal haematological, renal, cardiac and hepatic functions"}
- {"criterion_text":"- At diagnosis : Planned neoadjuvant chemotherapy"}
- {"criterion_text":"- At diagnosis : Written informed consent from patients and/or their parents/guardians before enrolment and any study-related procedure"}
- {"criterion_text":"- At diagnosis : Affiliation to a social insurance regimen"}
- {"criterion_text":"- For the randomisation : Patient with a histologically proven, confirmed by expert pathologists panel (before surgery at the latest), high-grade osteosarcoma"}
- {"criterion_text":"- For the randomisation : Registered at diagnosis into the study"}
- {"criterion_text":"- For the randomisation : Primary tumour resected after pre-operative chemotherapy"}
Exclusion criteria
- {"criterion_text":"- Low grade osteosarcoma, parosteal or periosteal osteosarcoma"}
- {"criterion_text":"- Concurrent use with high-dose non-steroidal anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors)"}
- {"criterion_text":"- Inflammatory or auto-immune disease, allergy or asthma requiring a chronic use of steroid treatment that cannot be stopped"}
- {"criterion_text":"- Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)"}
- {"criterion_text":"- Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection"}
- {"criterion_text":"- Prior history of other malignancies other than osteosarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years"}
- {"criterion_text":"- Osteosarcoma with multiple metastases for whom complete removal is not expected to be feasible even after shrinkage with chemotherapy"}
- {"criterion_text":"- Progressive disease at any site during initial pre-operative chemotherapy, confirmed before randomisation time, with exception of patients with progressive disease of the primary tumour who had a complete resection at surgery"}
- {"criterion_text":"- Any medical condition precluding treatment with protocol post-operative chemotherapy"}
- {"criterion_text":"- Fractional Shortening < 28% or LVEF< 50% before treatment (only for API post-operative chemotherapy) by echocardiogram or Muga scan"}
- {"criterion_text":"- Pregnancy or breast-feeding"}
- {"criterion_text":"- Hypersensitivity to the active substance or to any of the excipients"}
- {"criterion_text":"- Concurrent use of immunodepressive treatment such as cyclosporine, tacrolimus or other calcineurin inhibitors"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Event-free survival (EFS) estimated from the randomisation date to the time of first event (loco-regional or distant relapse or progression, second malignancy, death from any cause). Observations will be censored at the date of last follow-up visit for the patients remaining in first complete remission.","definition_or_measurement_approach":"EFS measured from randomisation to first event (loco-regional or distant relapse or progression, second malignancy, or death from any cause); censoring at date of last follow-up for patients in first complete remission."}
Secondary endpoints
- {"endpoint_text":"- Overall survival (OS) from the randomisation date to the date of death, whatever the cause of death.","definition_or_measurement_approach":"OS measured from randomisation to date of death from any cause."}
- {"endpoint_text":"- Progression Free-survival (PFS) from the randomisation date to the date of disease progression (radiological or clinical) or death of any cause, whichever occurs first. Observations will be censored at the date of last follow-up visit for the patients remaining in first complete remission.","definition_or_measurement_approach":"PFS measured from randomisation to radiological or clinical progression or death; censoring at last follow-up for patients in first complete remission."}
- {"endpoint_text":"- Feasibility of the planned treatment with calculation of cumulative dose and dose intensity of mifamurtide and chemotherapy","definition_or_measurement_approach":"Assessment of feasibility via calculation of cumulative doses and dose intensity for mifamurtide and concomitant chemotherapy as administered per protocol."}
- {"endpoint_text":"- Safety : all adverse events (NCI-CTCAE v5) will be analysed except AE unequivocally related to the underlying disease or its progression/relapse.","definition_or_measurement_approach":"Safety assessed by analysis of all adverse events graded by NCI-CTCAE v5, excluding AEs clearly related to underlying disease or progression/relapse."}
- {"endpoint_text":"- Long-term toxicity","definition_or_measurement_approach":"Assessment of long-term treatment-related toxicities (no detailed measurement approach specified)."}
- {"endpoint_text":"- Biomarkers to evaluate mifamurtide mechanisms of action and resistance","definition_or_measurement_approach":"Evaluation of biomarkers through associated translational research to study mechanisms of action and resistance to mifamurtide (methods not specified in the available text)."}
Recruitment
- Planned Sample Size
- 315
- Recruitment Window Months
- 179
- Consent Approach
- Dated and signed written informed consent required prior to any study-specific procedures. For minors, consent must be provided by parents/guardians ("Written informed consent from patients and/or their parents/guardians before enrolment and any study-related procedure"). A specific assent process or age-specific consent documents and languages available are not described in the provided documentation.
Geography
- Total Number Of Sites
- 37
- Total Number Of Participants
- 315
France
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 10-07-2024
- Processing Time Days
- 14
- Number Of Sites
- 37
- Number Of Participants
- 315
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Oncologie pédiatrique
- Principal Investigator Name
- Gabriel REVON-RIVIERE
- Principal Investigator Email
- gabriel.revon-riviere@ap-hm.fr
- Contact Person Name
- Gabriel REVON-RIVIERE
- Contact Person Email
- gabriel.revon-riviere@ap-hm.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Cancérologie de l’enfant et l’adolescent
- Principal Investigator Name
- Nathalie GASPAR
- Principal Investigator Email
- Nathalie.GASPAR@gustaveroussy.fr
- Contact Person Name
- Nathalie GASPAR
- Contact Person Email
- Nathalie.GASPAR@gustaveroussy.fr
- Site Name
- Institut De Cancerologie De Lorraine
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Anne KIEFFER
- Principal Investigator Email
- a.kieffer@nancy.unicancer.fr
- Contact Person Name
- Anne KIEFFER
- Contact Person Email
- a.kieffer@nancy.unicancer.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Onco-pédiatrie
- Principal Investigator Name
- Cyril LERVAT
- Principal Investigator Email
- c-lervat@o-lambret.fr
- Contact Person Name
- Cyril LERVAT
- Contact Person Email
- c-lervat@o-lambret.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Nelly FIRMIN
- Principal Investigator Email
- Nelly.firmin@icm.unicancer.fr
- Contact Person Name
- Nelly FIRMIN
- Contact Person Email
- Nelly.firmin@icm.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Emmanuelle BOMPAS
- Principal Investigator Email
- emmanuelle.bompas@ico.unicancer.fr
- Contact Person Name
- Emmanuelle BOMPAS
- Contact Person Email
- emmanuelle.bompas@ico.unicancer.fr
- Site Name
- Institut De Cancerologie Strasbourg Europe
- Department Name
- Onco-hématologie
- Principal Investigator Name
- Jean-Emmanuel KURTZ
- Principal Investigator Email
- je.kurtz@icans.eu
- Contact Person Name
- Jean-Emmanuel KURTZ
- Contact Person Email
- je.kurtz@icans.eu
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Joy BENADIBA
- Principal Investigator Email
- benadiba.j@chu-nice.fr
- Contact Person Name
- Joy BENADIBA
- Contact Person Email
- benadiba.j@chu-nice.fr
- Site Name
- Centre Leon Berard
- Department Name
- Hémato-oncologie pédiatrique
- Principal Investigator Name
- Perrine MAREC-BERARD
- Principal Investigator Email
- perrine.marec-berard@ihope.fr
- Contact Person Name
- Perrine MAREC-BERARD
- Contact Person Email
- perrine.marec-berard@ihope.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Claire PLUCHARD
- Principal Investigator Email
- cpluchart@chu-reims.fr
- Contact Person Name
- Claire PLUCHARD
- Contact Person Email
- cpluchart@chu-reims.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Natacha ENTZ-WERLE
- Principal Investigator Email
- natacha.entz-werle@chru-strasbourg.fr
- Contact Person Name
- Natacha ENTZ-WERLE
- Contact Person Email
- natacha.entz-werle@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Florence DUFFAUD
- Principal Investigator Email
- florence.duffaud@ap-hm.fr
- Contact Person Name
- Florence DUFFAUD
- Contact Person Email
- florence.duffaud@ap-hm.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Alice HERVIEU
- Principal Investigator Email
- ahervieu@cgfl.fr
- Contact Person Name
- Alice HERVIEU
- Contact Person Email
- ahervieu@cgfl.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Thibaud VALENTIN
- Principal Investigator Email
- Valentin.thibaud@iuct-oncopole.fr
- Contact Person Name
- Thibaud VALENTIN
- Contact Person Email
- Valentin.thibaud@iuct-oncopole.fr
- Site Name
- CHU Besancon
- Department Name
- Hémato-Onco-pédiatrie
- Principal Investigator Name
- Sébastien KLEIN
- Principal Investigator Email
- s1klein@chu-besancon.fr
- Contact Person Name
- Sébastien KLEIN
- Contact Person Email
- s1klein@chu-besancon.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Laure SAUMET
- Principal Investigator Email
- l-saumet@chu-montpellier.fr
- Contact Person Name
- Laure SAUMET
- Contact Person Email
- l-saumet@chu-montpellier.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Jean-Yves BLAY
- Principal Investigator Email
- jean-yves.blay@lyon.unicancer.fr
- Contact Person Name
- Jean-Yves BLAY
- Contact Person Email
- jean-yves.blay@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Leslie ANDRY
- Principal Investigator Email
- andry.leslie@chu-amiens.fr
- Contact Person Name
- Leslie ANDRY
- Contact Person Email
- andry.leslie@chu-amiens.fr
- Site Name
- Pellegrin Hospital
- Department Name
- Hémato-oncologie pédiatrique
- Principal Investigator Name
- Cecile VERITE
- Principal Investigator Email
- cecile.verite@chu-bordeaux.fr
- Contact Person Name
- Cecile VERITE
- Contact Person Email
- cecile.verite@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Hématologie et Cancérologie pédiatrique
- Principal Investigator Name
- Christophe PIGUET
- Principal Investigator Email
- christophe.piguet@chu-limoges.fr
- Contact Person Name
- Christophe PIGUET
- Contact Person Email
- christophe.piguet@chu-limoges.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Marianna DEPARIS
- Principal Investigator Email
- deparis-m@chu-caen.fr
- Contact Person Name
- Marianna DEPARIS
- Contact Person Email
- deparis-m@chu-caen.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Hémato-Immuno-Oncologie Pédiatrique
- Principal Investigator Name
- Pascale SCHNEIDER
- Principal Investigator Email
- pascale.schneider@chu-rouen.fr
- Contact Person Name
- Pascale SCHNEIDER
- Contact Person Email
- pascale.schneider@chu-rouen.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Christophe PERRIN
- Principal Investigator Email
- c.perrin@rennes.unicancer.fr
- Contact Person Name
- Christophe PERRIN
- Contact Person Email
- c.perrin@rennes.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Morgane CLEIREC
- Principal Investigator Email
- morgane.cleirec@chu-nantes.fr
- Contact Person Name
- Morgane CLEIREC
- Contact Person Email
- morgane.cleirec@chu-nantes.fr
- Site Name
- CHRU De Nancy
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Ludovic MANSUY
- Principal Investigator Email
- lu.mansuy@chru-nancy.fr
- Contact Person Name
- Ludovic MANSUY
- Contact Person Email
- lu.mansuy@chru-nancy.fr
- Site Name
- Institut Godinot
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Pauline SOIBINET-OUDOT
- Principal Investigator Email
- Pauline.soibinet@reims.unicancer.fr
- Contact Person Name
- Pauline SOIBINET-OUDOT
- Contact Person Email
- Pauline.soibinet@reims.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Hema-Immuno-Oncologie
- Principal Investigator Name
- Marie-Pierre CASTEX
- Principal Investigator Email
- castex.mp@chu-toulouse.fr
- Contact Person Name
- Marie-Pierre CASTEX
- Contact Person Email
- castex.mp@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Florence NEUMANN
- Principal Investigator Email
- florent.neumann@chu-dijon.fr
- Contact Person Name
- Florence NEUMANN
- Contact Person Email
- florent.neumann@chu-dijon.fr
- Site Name
- Centre Hospitalier Regional D'Angers
- Department Name
- Oncologie pédiatrique
- Principal Investigator Name
- Stephanie PROUST
- Principal Investigator Email
- stproust@chu-angers.fr
- Contact Person Name
- Stephanie PROUST
- Contact Person Email
- stproust@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Chrystelle DUPRAZ
- Principal Investigator Email
- c.dupraz@chu-poitiers.fr
- Contact Person Name
- Chrystelle DUPRAZ
- Contact Person Email
- c.dupraz@chu-poitiers.fr
- Site Name
- Institut Bergonie
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Antoine ITALIANO
- Principal Investigator Email
- a.italiano@bordeaux.unicancer.fr
- Contact Person Name
- Antoine ITALIANO
- Contact Person Email
- a.italiano@bordeaux.unicancer.fr
- Site Name
- Trousseau Hospital
- Department Name
- Hématologie et Oncologie
- Principal Investigator Name
- Marie-Dominique TABONE
- Principal Investigator Email
- marie-dominique.tabone@aphp.fr
- Contact Person Name
- Marie-Dominique TABONE
- Contact Person Email
- marie-dominique.tabone@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Service de médecine de l’enfant et de l’adolescent, Unité d’hémato-oncologie
- Principal Investigator Name
- Sophie TAQUE
- Principal Investigator Email
- sophie.taque@chu-rennes.fr
- Contact Person Name
- Sophie TAQUE
- Contact Person Email
- sophie.taque@chu-rennes.fr
- Site Name
- Grenoble University Hospital Center
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Severine BOBILLIER-CHAUMONT
- Principal Investigator Email
- sbobillierchaumont@chu-grenoble.fr
- Contact Person Name
- Severine BOBILLIER-CHAUMONT
- Contact Person Email
- sbobillierchaumont@chu-grenoble.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Cancérologie
- Principal Investigator Name
- Pascaline BOUDOU ROUQUETTE
- Principal Investigator Email
- pascaline.boudou@aphp.fr
- Contact Person Name
- Pascaline BOUDOU ROUQUETTE
- Contact Person Email
- pascaline.boudou@aphp.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Sarah DUMONT
- Principal Investigator Email
- sarah.dumont@gustaveroussy.fr
- Contact Person Name
- Sarah DUMONT
- Contact Person Email
- sarah.dumont@gustaveroussy.fr
- Site Name
- Institut Curie
- Department Name
- Oncologie pédiatrique
- Principal Investigator Name
- Sarah WINTER
- Principal Investigator Email
- Sarah.Winter@curie.fr
- Contact Person Name
- Sarah WINTER
- Contact Person Email
- Sarah.Winter@curie.fr
- Site Name
- Centre Hospitalier Universitaire De La Reunion
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Stéphanie GOURDON
- Principal Investigator Email
- stephanie.gourdon@chu-reunion.fr
- Contact Person Name
- Stéphanie GOURDON
- Contact Person Email
- stephanie.gourdon@chu-reunion.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Bérengère NARCISO
- Principal Investigator Email
- berengere.narciso@univ-tours.fr
- Contact Person Name
- Bérengère NARCISO
- Contact Person Email
- berengere.narciso@univ-tours.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Hematologie et Oncologie pédiatrique
- Principal Investigator Name
- Jill SERRE
- Principal Investigator Email
- j.serre@chu-tours.fr
- Contact Person Name
- Jill SERRE
- Contact Person Email
- j.serre@chu-tours.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- François BERTUCCI
- Principal Investigator Email
- bertuccif@ipc.unicancer.fr
- Contact Person Name
- François BERTUCCI
- Contact Person Email
- bertuccif@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Hématologie et Cancérologie pédiatrique
- Principal Investigator Name
- Claire BERGER
- Principal Investigator Email
- claire.berger@chu-st-etienne.fr
- Contact Person Name
- Claire BERGER
- Contact Person Email
- claire.berger@chu-st-etienne.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Justyna KANOLD
- Principal Investigator Email
- jkanold@chu-clermontferrand.fr
- Contact Person Name
- Justyna KANOLD
- Contact Person Email
- jkanold@chu-clermontferrand.fr
- Site Name
- Institut Curie
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Sophie PIPERNO-NEUMANN
- Principal Investigator Email
- sophie.piperno-neumann@curie.fr
- Contact Person Name
- Sophie PIPERNO-NEUMANN
- Contact Person Email
- sophie.piperno-neumann@curie.fr
Sponsor
Primary sponsor
- Full Name
- Unicancer
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Third parties
- {"country":"","full_name":"PHRC","duties_or_roles":"","organisation_type":""}
- {"country":"","full_name":"TAKEDA","duties_or_roles":"","organisation_type":""}
Investigational products
- Investigational Product Name
- MEPACT 4 mg powder for concentrate for dispersion for infusion
- Active Substance
- MIFAMURTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- EU/1/08/502/001
- Maximum Dose
- 2 mg/m2 milligram(s)/sq. meter (maxDailyDoseAmount value provided)
- Investigational Product Name
- DOXORUBICIN HYDROCHLORIDE
- Active Substance
- DOXORUBICIN HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 60 mg/m2 milligram(s)/sq. meter (maxDailyDoseAmount value provided)
- Investigational Product Name
- IFOSFAMIDE
- Active Substance
- IFOSFAMIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 3 gm/m2 gram(s)/square meter (maxDailyDoseAmount value provided)
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 100 mg/m2 milligram(s)/sq. meter (maxDailyDoseAmount value provided)
- Investigational Product Name
- METHOTREXATE
- Active Substance
- METHOTREXATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 12 gm/m2 gram(s)/square meter (maxDailyDoseAmount value provided)
- Investigational Product Name
- ETOPOSIDE
- Active Substance
- ETOPOSIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 75 mg/m2 milligram(s)/sq. meter (maxDailyDoseAmount value provided)
- Combination Treatment
- Yes
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