Title (COG ANBL0032) Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
Principal Investigator Martin Brecher, MD
Study Number 63405
Summary The primary objective of this study is to determine if monoclonal antibody CH14.18 +cytokinews+isotretinoin improves event free survival after myeloablative therapy and stem cell rescue as compared to RA alone, in high risk neuroblastoma pts who have achieved a pre-ASCT response of CR, VGPR, or PR.
- Patients must be diagnosed with neuroblastoma, enrolled on ANBL00BI and categorized as high risk at time of diagnosis.
- Must be less than or equal to 30.99 years of age at diagnosis.
- All patients must have completed therapy including intensive induction followed by ASCT and radiotherapy to be eligible for ANBL0032. **Radiotherapy may be waived for patients who either have small adrenal masses which are completely resected up front, or who never have an identifiable primary tumor. Please Notify Study Chairs. Examples of such therapies include: Following treatment per A3973 protocol; Following treatment per POG 9341/9342 protocol; Enrollment on ANBL02P1; Enrollment on or following treatment per ANBL02P1, Tandem transplant patients are eligible: following enrollment and treatment on or per ANBL0532, Following treatment per POG 9640, Following treatment per COG ANBL00P1; or Following treatment per CHP 594/DFCI 34-DAT
- No more than 9 months from date of starting first induction chemotherapy after diagnosis to date of ASCT, except for the rare occasions as noted below. For tandem ASCT patients, this will be the date of the FIRST stem cell infusion. EXCEPTION: for those who are intially diagnosed as non-high risk neuroblasoma, but later converted (and/or relapsed) to high risk neuroblastoma, the 9 months restriction should start from the date of induction therapy for high-risk neurblastoma (Not from the initial induction therapy for non-high risk disease) to the date of ASCT.
- Prior to Enrollment on ANBL0032, a determination of residual disease must be performed (tumor imaging studies including CT or MRI, MIBG scan, bone marrow aspiration & biopsy and blood and bone marrow samples). This disease assessment is required for eligibility.
- Patients must be enrolled before treatment begins. The date protocol therapy is projected to start must be no later than 10 calendar days after the date of study enrollment.
- Informed consent should be obtained within 3 weeks pre-ASCT up to the time of registration.
- Patient must not have progressive disease or biopsy proved residual disease.
- Must have Lansky or Karnofsky performance scale score of greater than or equal to 50% and have a life expectancy of greater than or equal to two months.
- Must have adequate organ function (renal, hepatic, cardiac, pulmonary, central nervous system) at time of registration.
- Females of childbearing potential must have a negative pregnancy test.