Clinical Trials /

Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma

NCT02100930

Description:

The purpose of this study is to be able to supply an experimental combination of drugs called 3F8 and GM-CSF (also called sargramostim) to patients with high-risk neuroblastoma who may benefit from treatment.

Related Conditions:
  • Neuroblastoma
Recruiting Status:

Completed

Phase:

N/A

Trial Eligibility

Document

Anti-GD2 3F8 Monoclonal <span class="go-doc-concept go-doc-intervention">Antibody</span> and <span class="go-doc-concept go-doc-intervention">GM-CSF</span> for High-Risk <span class="go-doc-concept go-doc-disease">Neuroblastoma</span>

Title

  • Brief Title: Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma
  • Official Title: Anti-GD2 3F8 Monoclonal Antibody and GM-CSF for High-Risk Neuroblastoma
  • Clinical Trial IDs

    NCT ID: NCT02100930

    ORG ID: 13-260

    Trial Conditions

    Neuroblastoma

    Trial Interventions

    Drug Synonyms Arms
    GM-CSF (granulocyte-macrophage colony-stimulating factor) Neuroblastoma
    oral isotretinoin Neuroblastoma

    Trial Purpose

    The purpose of this study is to be able to supply an experimental combination of drugs
    called 3F8 and GM-CSF (also called sargramostim) to patients with high-risk neuroblastoma
    who may benefit from treatment.

    Detailed Description

    This treatment uses 3F8/GM-CSF and isotretinoin for: Group 1 patients are in 1st CR/VGPR;
    Group 2 patients are in a 2nd CR/VGPR; and Group 3 patients have primary refractory NB in
    BM. All patients will receive 3F8/GM-CSF through 24 months.

    Road Map/Schema for Group 1 (1st CR/VGPR) and Group 2 (2nd CR/VGPR) patients:

    Cycle 1 3F8 (iv) + GM-CSF subcutaneous (sc) (1 wk) 2-4-wk interval Cycle 2 3F8 (iv) + GM-CSF
    (sc) (1 wk) 2-4-wk interval* - oral isotretinoin x14 days Cycle 3 3F8 (iv) + GM-CSF (sc) (1
    wk) 2-4-wk interval - oral isotretinoin x14 days Cycle 4 3F8 (iv) + GM-CSF (sc) (1 wk)
    6-8-wk interval - oral isotretinoin x14 days on, 14 days off, 14 days on Cycle 5 3F8 (iv) +
    GM-CSF (sc) (1 wk) 6-8-wk interval - oral isotretinoin x14 days on, 14 days off, 14 days on
    (6th cycle) Cycle 6 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk interval Cycle 7 3F8 (iv) + GM-CSF
    (sc) (1 wk) Continue with 6-8-wk intervals through 24 months from 1st dose of 3F8. *
    assessment of BM status by standard histology

    Road Map/Schema for Group 3 patients (BM positive): The break between end of a cycle of
    3F8/GM-CSF and start of next cycle is approximately 2-to-4-weeks through 4 cycles after
    achievement of CR in BM; subsequent breaks are ~6-8 weeks. Please see roadmap below for a
    patient achieving CR in BM after cycle 1. Cycle 1 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk
    interval* - BM negative Cycle 2 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk interval* - oral
    isotretinoin x14 days Cycle 3 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk interval - oral
    isotretinoin x14 days Cycle 4 3F8 (iv) + GM-CSF (sc) (1 wk) 2-4-wk interval - oral
    isotretinoin x14 days Cycle 5 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk interval - oral
    isotretinoin x14 days Cycle 6 3F8 (iv) + GM-CSF (sc) (1 wk) 6-8-wk interval - oral
    isotretinoin x14 days on, 14 days off, 14 days on (6th cycle) Cycle 7 3F8 (iv) + GM-CSF (sc)
    (1 wk) 6-8-wk interval Continue with 6-8-wk intervals through 24 months from 1st dose of
    3F8.

    * assessment of BM response by standard histology

    Trial Arms

    Name Type Description Interventions
    Neuroblastoma Experimental This is a single-arm, open label, open access study to provide the anti-GD2 murine IgG3 MoAb 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with high-risk neuroblastoma (NB). This immunotherapy has shown efficacy against minimal residual disease (MRD) in such patients. GM-CSF (granulocyte-macrophage colony-stimulating factor), oral isotretinoin

    Eligibility Criteria

    Inclusion Criteria:

    - Diagnosis of NB as defined by international criteria,62 i.e., histopathology
    (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine
    catecholamine levels.

    - High-risk NB, as defined by risk-related treatment guidelines and the International
    NB Staging System, i.e., stage 4 with (any age) or without (>18 months)
    MYCNamplification, 63 or MYCN-amplified NB other than stage 1.64,65

    - Patients are in CR/VGPR or have primary refractory NB in BM - i.e., NB resistant to
    standard therapy, as evidenced by persistence of NB in BM by histology or MIBG scan,
    but all other findings in scans show VGPR.

    - Children and adults are eligible.

    - Signed informed consent indicating awareness of the scheduling and side effects, as
    well as testing requirements, of this program.

    Exclusion Criteria:

    - Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic,
    pulmonary, or gastrointestinal toxicity > or = to grade 3, except for grade 3
    hematologic toxicity.

    - Progressive disease (PD)

    - History of allergy to mouse proteins.

    - Active life-threatening infection.

    - Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml.

    - Pregnant women

    - Inability to comply with protocol requirements.

    Minimum Eligible Age: N/A

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    relapse-free survival

    complete remission

    Secondary Outcome Measures

    Trial Keywords

    Anti-GD2 3F8 Monoclonal Antibody

    oral isotretinoin

    GM-CSF

    Sargramostim

    13-260