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ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma

Information source: United Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuroblastoma

Intervention: ch14.18 -NCI (Biological); ch14.18-UTC (Biological); Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (Biological); Aldesleukin (IL-2) (Biological); Isotretinoin (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: United Therapeutics

Official(s) and/or principal investigator(s):
Araz Marachelian, MD, Study Chair, Affiliation: Children's Hospital Los Angeles

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]).

Clinical Details

Official title: A Comparative Pharmacokinetic and Safety Study of Chimeric Monoclonal Antibody ch14.18 With Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Interleukin-2 (IL-2) and Isotretinoin in High Risk Neuroblastoma Patients Following Myeloablative Therapy

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Area under the plasma concentration curve (AUC)

Secondary outcome: Adverse Events

Detailed 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.

Eligibility

Minimum age: N/A. Maximum age: 8 Years. Gender(s): Both.

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

Locations and Contacts

Children's Hospital of Los Angeles, Los Angeles, California 90027, United States

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia 30322, United States

The University of Chicago, Chicago, Illinois 60637, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02215, United States

University of Michigan C.S. Mott Children's Hospital, Ann Arbor, Michigan 48109, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota 55404, United States

Children's Mercy Hospital (Kansas), Kansas, Missouri 64108, United States

Washington University School of Medicine, St. Louis, Missouri 63310, United States

Columbia University Medical Center, New York, New York 10032, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Cook Children's Medical Center, Fort Worth, Texas 76104, United States

Seattle Children's Hospital, Seattle, Washington 98105, United States

Additional Information

Starting date: August 2012
Last updated: March 20, 2015

Page last updated: August 23, 2015

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