ANBL - 32 Clinical Trial; Post Primary Protocol

Abdullah is now a a candidate for a phase 3 immunotherapy clinical trial. This is the hardest decision making we are faced with yet in the treatment of our child. How can one rationalize to put their child through another 6 months of hospital, with at minimum a lot of pain, not knowing whether or not this trial will be beneficial in any way.

Description:
This study is being done to determine if monoclonal antibody Ch14.18 + cytokines + isotretinoin (13-cis-retinoic acid or RA) improves event free survival after myeloablative therapy and stem cell rescue as compared to RA alone in high risk patients with neuroblastoma who have achieved a pre-ASCT response of CR, VGPR, or PR. Patients will be randomized into one of two treatment arms (Regimen A or Regimen B). Patients in Regimen A will receive the drug cis-RA approximately 2 months following stem cell transplant. Patients begin 6 monthly treatments with 13-cis-retinoic acid and will take this drug by mouth twice a day for 14 days and then not take it for the following 14 days. This 28-day course will be repeated 6 times. Regimen B involves treatment with cis-RA as well as the experimental agent, C14.18, GM-CSF, and IL-2. Regimen B is given over six 28-day courses; there may be different combinations of drugs in the courses.

Criteria:
1. Patients must have a confirmed diagnosis of neuroblastoma, and categorized as high risk at the time of diagnosis. 2. Patients must not be older than 30 at diagnosis. 3. If patient is enrolled in study A3973, then the patient must have completed front-line therapy followed by ASCT and radiotherapy as outlined in A3973, AND have achieved CR, VGPR or PR at pre-ASCT evaluation. 4. If a patient is not enrolled on the study A3973, the patient will be eligible for this study if they are CR/VGPR/PR after treatment with one of the study designated induction regimens prior to a single cycle of high-dose therapy and ASCT. 5. No later than 9 months from the date of starting the first induction chemotherapy after diagnosis to the date of autologous stem cell transplantation should elapse. 6. Patients must not have progressive disease or biopsy proven residual disease if not enrolled on the study A3973 at the time of enrollment in this study. 7. Patients must have adequate renal, liver, cardiac, pulmonary and central nervous function.