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

NCT02100930 | Completed Results FDA Drug

• 1 other identifier: 13-260
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuroblastoma

Keywords

Anti-GD2 3F8 Monoclonal Antibody; oral isotretinoin; GM-CSF; Sargramostim; 13-260

Outcome Measures

Primary Outcomes (2)

• Therapeutic Response

  Disease status is defined by the International Neuroblastoma Response Criteria - Complete response/remission (CR): NED; Partial response/remission: \>50% decrease in all disease parameters, exceptbone scan unchanged or improved; no more than 1 positive bone marrow site; Stable disease: \<50% decrease in all tumor markers; Progressive disease (PD): new lesion, or \>25 % increase in any disease marker.

  2 years

• Complete Remission

  Disease status is defined by the International Neuroblastoma Response Criteria - Complete response/remission (CR): NED; Partial response/remission: \>50% decrease in all disease parameters, exceptbone scan unchanged or improved; no more than 1 positive bone marrow site; Stable disease: \<50% decrease in all tumor markers; Progressive disease (PD): new lesion, or \>25 % increase in any disease marker.

  2 years

Study Arms (1)

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.

Biological: Anti-GD2 3F8 Monoclonal Antibody; Drug: GM-CSF (granulocyte-macrophage colony-stimulating factor); Drug: oral isotretinoin

Interventions

Anti-GD2 3F8 Monoclonal Antibody BIOLOGICAL

Neuroblastoma

GM-CSF (granulocyte-macrophage colony-stimulating factor) DRUG

Neuroblastoma

oral isotretinoin DRUG

Neuroblastoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Neuroblastoma

Interventions

humanized 3F8 anti-GD2 monoclonal antibody; Granulocyte-Macrophage Colony-Stimulating Factor; Isotretinoin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological

Results Point of Contact

• Title: Dr. Brian Kushner, MD
• Organization: Memorial Sloan Kettering Cancer Center

kushnerb@mskcc.org

212-639-6793

Study Officials

• Brian Kushner, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 1, 2014
• Study Start: March 1, 2014
• Primary Completion: March 7, 2019
• Study Completion: March 7, 2019
• Last Updated: February 28, 2020
• Results First Posted: February 28, 2020

Record last verified: 2019-04

Locations

US (1)