ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics [UTC] or the National Cancer Institute [NCI]).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United Therapeutics
• Treatments: Aldesleukin; Antibodies, Monoclonal; Dinutuximab; Isotretinoin; Molgramostim; Sargramostim; Tretinoin

Criteria

Inclusion Criteria:

• Diagnosis of high-risk neuroblastoma

• 8 years of age or younger at diagnosis of high-risk neuroblastoma

• Patients must have completed therapy including intensive induction followed by autologous stem cell transplantation (ASCT) and radiotherapy

• 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

• 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 ≤ 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 12 months from starting the first induction chemotherapy after diagnosis to the date of ASCT

• For patients who became high-risk neuroblastoma after initial non-high risk disease, the 12 months period should start from the date of induction therapy for high-risk neuroblastoma to the date of ASCT

• No progressive disease at time of registration except for protocol-specified bone marrow response

• Adequate hematological, renal, hepatic, pulmonary and cardiac function

• CNS toxicity < Grade 2

Exclusion Criteria:

• Prior anti-GD2 antibody therapy

• Prior vaccine therapy for neuroblastoma

• Concurrent anti-cancer or immunosuppressive therapy