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
- Conditions
- cancerneuroblastoma10029211
- Registration Number
- NL-OMON44066
- Lead Sponsor
- Stichting Kinderoncologie Nederland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 16
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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety (toxic deaths) and tolerability (relevant grade 4 toxicities) for the<br /><br>three treatment arms.</p><br>
- Secondary Outcome Measures
Name Time Method