Immunotherapy for patients with high risk neuroblastoma
- Conditions
- Recurrent, progressive or newly diagnosed high risk neuroblastomaMedDRA version: 18.1Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004481-34-NL
- Lead Sponsor
- niversity of Cologne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
Established diagnosis of neuroblastoma according to the international INSS criteria
High risk (HR): stage 4 over 18 months of age and MYCN amplified neuroblastoma of any stage and any age
- Recurrent or progressive neuroblastoma: completed re-induction chemotherapy (Germany and The Netherlands)
- Newly diagnosed neuroblastoma: Complete front-line treatment including induction chemotherapy, surgical removal and/ or local irradiation of the primary tumor and myeloablative chemotherapy with autologous stem cell reinfusion according to the actual guidelines of the GPOH/ DCOG (in The Netherlands only).
Achieved response status: stable disease or better (CR, VGPR, PR, SD) at the end of re-induction chemotherapy in recurrent disease and after ASCT in newly diagnosed disease
Written informed consent of parents or guardian and – if appropriate – of the patient.
For at least two weeks prior to start of trial medication
- off any standard or experimental treatment (and fully recovered from short-term major toxic effects)
- no tumour surgery (and fully recovered from any post-surgical complications)
- no immediate requirements for palliative chemotherapy, radiotherapy or surgery
The patient may have had prior CNS metastases provided the following criteria are all met:
- The patient’s CNS disease has been previously treated
- The patient’s CNS disease has been clinically stable for four weeks prior to starting this study (assessed clinically and by MRI or CT)
- The patient is off steroids for four weeks prior to starting the study and will not require them during the course of the study
- A patient with seizure disorders may be enrolled if well controlled on anticonvulsants and if no seizures have occurred within a 6 week period prior to starting trial treatment
HIV sero-negative and neither active nor chronic-replicative hepatitis B infection
adequate functions of the cor, lung, bone marrow, liver, kidney
Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Significant intercurrent illnesses and/or any of the following:
- Symptoms of congestive heart failure or of uncontrolled cardiac arrhythmia
- Significant psychiatric disabilities or psychological conditions preventing treatment realization
- Uncontrolled seizure disorders
- Active infections
- Clinically significant neurologic deficit or objective peripheral neuropathy (> grade 2)
- Significant, symptomatic pleural effusions
Requirement or likely requirement for corticosteroids or other immunosuppressive drugs (except the medications recommended for conditions mentioned in the protocol)
Platelet transfusion dependency
Concurrent treatment with any non-trial anticancer therapy or interventional study
Positive pregnancy test, lactation
Sexually active patients (male and female) at reproductive age not willing to use highly effective contraceptive methods according to the guidelines ICH M3
Neuroblastoma patients with actively progressing disease
Patients with HACA detected after previous antiGD2 immunotherapy
Known allergy or contraindications against one of the study drugs (IMP)
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