An international study comparing two treatment strategies for metastatic neuroblastoma patients with poor response to induction chemotherapy
- Conditions
- Metastatic High Risk NeuroblastomaMedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-003130-27-GB
- Lead Sponsor
- Gustave Roussy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
1.Metastatic neuroblastoma (NBL)
2.Previously treated within the SIOPEN High Risk Neuroblastoma study or treated with the current standard treatment for very high risk neuroblastoma off-trial (Rapid COJEC induction chemotherapy)
3.131I-mIBG scintigraphy positive at diagnosis and after induction chemotherapy (pre BuMel evaluation).
4.Metastatic response after induction chemotherapy lower than the SIOPEN High Risk Neuroblastoma trial criteria to be eligible for high dose chemotherapy (metastatic response worse than partial response (< PR) or SIOPEN score > 3)
5.Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use acceptable and appropriate contraception while on study drug and for one year after stopping the study drug. Acceptable contraception is listed in Appendix 12. Female patients who are lactating must agree to stop breast-feeding.
6.Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines.
7.Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1.Parenchymal brain metastasis(es) (even one)
2.Progressive disease at study entry
3.Previous high-dose therapy and ASCR
4.Performance status (Karnofsky or Lansky) <70%
5.Patient having received other therapy for cancer treatment than those allowed as per the SIOPEN High Risk Neuroblastoma trial or as defined in the future frontline protocol (for HRNBL1 trial : after induction + 2 TVD)
6.Impaired organ function (liver, kidney, heart, lungs) according to the following definitions
oShortening fraction <28%, or ejection fraction <55%, or clinical evidence of congestive heart failure or uncontrolled cardiac rhythm disturbance
oDyspnea at rest and/or pulse oximetry <95% in air.
oALT, Bilirubin > 2 ULN
oCreatinine clearance and/or GFR < 60 ml/min/1.73m2 and serum creatinine = 1.5 mg/dl
7.Any uncontrolled inter-current illness or infection that in the investigator’s opinion would impair study participation
8.Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines
9.Patient allergic to peanut or soya
10.Chronic inflammatory bowel disease and/or bowel obstruction
11.Pregnant or breastfeeding women
12.Known hypersensitivity to the active substance or to any of the excipients of study drugs
13.Known hypersensitivity to dacarbazine
14.Concomitant use with St John's Wort
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method