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Neuroblastoma Protocol 2012: Therapy for Children With Advanced Stage High-Risk Neuroblastoma


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

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Trial Information

Neuroblastoma Protocol 2012: Therapy for Children With Advanced Stage High-Risk Neuroblastoma


The phases of the study are:

1. Screening phase: Tests and evaluations will be done before treatment starts.

2. Induction phase: Includes chemotherapy plus hu14.18K322A mAb. Participants will also
have surgery during this part of the study to remove as much tumor as possible.

3. Consolidation/Intensification phase: Includes high doses of chemotherapy and blood stem
cell transplantation with additional, experimental "minimal residual disease" (MRD)
treatment.. Participants will also get radiation treatment to all sites of the tumor(s)
after recovery from the stem cell transplant.5. Maintenance/MRD treatment phase: With
immune therapy in addition to the standard treatment with the drug isotretinoin.

4. Maintenance/MRD treatment phase: With immune therapy in addition to the standard
treatment with the drug isotretinoin.


PARTICIPANT

Inclusion Criteria:



- Participants <19 years of age (eligible until 19th birthday).

- Newly diagnosed, advanced stage, high-risk neuroblastoma defined as one of the
following:

- Children < 1 year with International Neuroblastoma Staging System (INSS) stage
2a, 2b, 3, 4 or 4S disease AND MYCN amplification (>10 copies, or greater than
four-fold increase in MYCN signal as compared to reference signal).

- INSS 2a or 2b disease AND MYCN amplification, regardless of age or additional
biologic features

- INSS stage 3 AND:

1. MYCN amplification (>10 copies, or greater than four-fold increase in MYCN
signal as compared to reference signal, regardless of age or additional
biologic features

2. Age > 18 months (> 547 days) with unfavorable pathology, regardless of MYCN
status

- INSS stage 4 and:

1. MYCN amplification, regardless of age or additional biologic features

2. Age > 18 months (> 547 days) regardless of biologic features

3. Age 12 - 18 months (365 - 547 days) with any of the following three
unfavorable biologic features (MYCN amplification, unfavorable pathology
and/or DNA index =1) or any biologic feature that is indeterminant/unknown

- Children at least 365 days initially diagnosed with: INSS stage 1, 2, 4S who
progressed to a stage 4 without interval chemotherapy.

- Histologic proof of neuroblastoma or positive bone marrow for tumor cells with
increased urine catecholamines.

- Adequate renal and hepatic function (serum creatinine <3 x upper limit of normal for
age, AST< 3 x upper limit of normal).

- No prior therapy, unless an emergency situation requires local tumor treatment
(discuss with principal investigator).

- Written, informed consent according to institutional guidelines.

PARTICIPANT Exclusion Criteria:

- Any evidence, as judged by the investigator, of severe or uncontrolled systemic
disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal
disease).

- Pregnant or breast feeding (female of child-bearing potential).

- Children with INSS 4 disease, age <18 months with all 3 favorable biologic features
(non-amplified MYCN, favorable pathology and DNA index >1).

DONOR

Inclusion Criteria:



- Potential donor is a biologic parent

- Potential donor is at least 18 years of age.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with complete or partial response

Outcome Description:

To study the efficacy [response: complete remission + partial remission (CR+PR)] to two initial courses of cyclophosphamide and topotecan combined with hu14.18K322A (4 doses/course followed by GM-CSF) in previously untreated children with high-risk neuroblastoma.

Outcome Time Frame:

after two initial courses of chemotherapy (approximately 6 weeks after enrollment)

Safety Issue:

No

Principal Investigator

Wayne L. Furman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

NB2012

NCT ID:

NCT01857934

Start Date:

May 2013

Completion Date:

June 2019

Related Keywords:

  • Neuroblastoma
  • Anti-GD2 monoclonal antibody
  • hu14.18K322A
  • High-risk neuroblastoma
  • Phase II
  • Allogeneic NK cells
  • Neuroblastoma

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794