EUCTR2013-004481-34-DEActive, not recruitingPhase 1
RANDOMIZED PHASE 2 TRIAL COMPARING EXPERIMENTAL IMMUNOTHERAPY (ANTI-GD2 ANTIBODY, IL-2 S.C.,GM-CSF) IN RECURRENT HIGH RISK NEUROBLASTOMA PATIENTS WITH STANDARD IMMUNOTHERAPY (ANTI-GD2 ANTIBODY, IL-2 I.V., GM-CSF) IN PATIENTS WITH RECURRENT AND NEWLY DIAGNOSED HIGH RISK NEUROBLASTOMA - NB2013-HR PILOT GPOH/DCOG
niversity of Cologne0 sites36 target enrollmentStarted: August 20, 2014Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 36
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Investigators
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