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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


Phase 1/Phase 2
N/A
8 Years
Open (Enrolling)
Both
Neuroblastoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Area under the plasma concentration curve (AUC)

Outcome Description:

Twenty-two PK samples will be obtained at the following timepoints: Courses 1 and 3: Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample Courses 2 and 4: Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Araz Marachelian, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Los Angeles

Authority:

United States: Food and Drug Administration

Study ID:

DIV-NB-201

NCT ID:

NCT01592045

Start Date:

August 2012

Completion Date:

July 2013

Related Keywords:

  • Neuroblastoma
  • Neuroblastoma

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Washington University School of MedicineSaint Louis, Missouri  63110
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
Duke University Medical CenterDurham, North Carolina  27710
The University of ChicagoChicago, Illinois  60637
Seattle Children's HospitalSeattle, Washington  98105
Columbia University Medical CenterNew York, New York  10032
Cook Children's Medical CenterFort Worth, Texas  76104
Children's Hospital of Los AngelesLos Angeles, California  90027
Children's Healthcare of Atlanta - EglestonAtlanta, Georgia  30322
Children's Mercy Hospital (Kansas)Kansas, Missouri  64108
University of Michigan C.S. Mott Children's HospitalAnn Arbor, Michigan  48109