ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma

Completed · Phase 1/Phase 2

Conditions studied: Neuroblastoma

In brief

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 \[NCI\]).

Key facts

Study ID

NCT01592045

Run by

United Therapeutics

People needed

28

Starts

2012-08-01

Expected to finish

2014-06-01

Last updated by the study team

2015-09-23

Who can join

Age: any, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior anti-GD2 antibody therapy
• Prior vaccine therapy for neuroblastoma
• Concurrent anti-cancer or immunosuppressive therapy

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
• The University of Chicago — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
• Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota, United States
• Children's Mercy Hospital (Kansas) — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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