ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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]).
Full description
This is a multi-center, randomized, open-label, two-sequence, cross-over study for eligible subjects with high-risk neuroblastoma to assess the comparability of ch14.18 manufactured with UTC drug product and ch14.18 manufactured with NCI drug product. Subjects will be randomly allocated to receive ch14.18 manufactured by UTC or NCI during Courses 1 and 2 followed by ch14.18 manufactured by other manufacturer (UTC or NCI) during Courses 3, 4, and 5.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Diagnosis of high-risk neuroblastoma
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8 years of age or younger at diagnosis of high-risk neuroblastoma
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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
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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
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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
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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
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No progressive disease at time of registration except for protocol-specified bone marrow response
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Adequate hematological, renal, hepatic, pulmonary and cardiac function
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CNS toxicity < Grade 2
Exclusion criteria
- Prior anti-GD2 antibody therapy
- Prior vaccine therapy for neuroblastoma
- Concurrent anti-cancer or immunosuppressive therapy
Trial design
Primary purpose
Allocation
Interventional model
Masking
28 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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