ANBL0032 Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
Johns Hopkins Kimmel Cancer Center in Baltimore
Randomized phase III trial to compare the effectiveness of chemotherapy with or without monoclonal antibody, interleukin-2, and sargramostim following stem cell transplantation in treating patients who have neuroblastoma.
Ages Eligible for Study: up to 30 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Diagnosis of neuroblastoma Categorized as high risk at diagnosis Meets all of the following criteria: Patients much have completed therapy including intensive induction followed by autologous stem cell transplantation (ASCT) and radiotherapy Completed frontline therapies, examples of such therapy includes: Following treatment per COG-A3973 protocol Following treatment per POG-9340-42 Following treatment per CCG-3891 Following treatment on NANT-2001-02 Enrollment on or following treatment per COG-ANBL02P1 protocol Enrollment on or following treatment per ANBL07P1 Tandem transplant patients are eligible Following enrollment and treatment on or per COG-ANBL0532 Following treatment per POG-9640 protocol Following treatment per COG-ANBL00P1 protocol Following treatment per CHP 594 or DFCI 34-DAT Other frontline therapy with permission from study chairs Patients with biopsy confirmed residual disease after ASCT are eligible Must meet the International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases, and bone metastases AND must also meet the protocol specified criteria for bone marrow response as follows: No more than 10% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy Patient who have no tumor seen on the prior bone marrow, and then have â?¤ 10% tumor on any of the bilateral marrow aspirate/biopsy specimens done at pre-ASCT and/or pre-enrollment evaluation will also be eligible No more than 9 months from starting the first induction chemotherapy after diagnosis to the date of ASCT * No progressive disease at time of registration except for protocol specified bone marrow response NOTE: * For tandem ASCT patients this is the date of the first stem cell infusion PATIENT CHARACTERISTICS: Age: 30 and under at diagnosis
This is a randomized, multicenter study. Patients are stratified according to pre-autologous stem cell transplantation (ASCT) response (complete vs very good partial vs partial), stem cells received (purged vs unpurged), and frontline chemotherapy (COG-A3973 vs POG 9341/9342 vs COG-ANGL02P1 vs other therapy). A further stratum consists of patients with biopsy-confirmed post-ASCT persistent disease who are also enrolled on COG-A3973 or COG-ANBL0532. These patients are not randomized but assigned to treatment arm II. Patients in the first set of strata are randomized to 1 of 2 treatment arms. Arm II: Beginning on day 56 post-ASCT, patients receive immunotherapy comprising sargramostim (GM-CSF) subcutaneously (SC) or IV over 2 hours on days 0-13 during courses 1, 3, and 5 and monoclonal antibody Ch14.18 IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive interleukin-2 IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral isotretinoin as in arm I beginning on day 11 of immunotherapy. Patients are followed periodically for 10 years.
07/01/2015 04:01 AM