Completed

Phase II Study of Anti-GD2 3F8 Antibody and GM-CSF for High-Risk Neuroblastoma

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What is being tested

anti-GD2 murine IgG3 monoclonal antibody 3F8

Biological
Who is being recruted

Neoplasms+7

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2003
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2003

Actual date on which the first participant was enrolled.

OBJECTIVES: * Determine the efficacy of sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk neuroblastoma. * Determine the prognostic impact of minimal residual bone marrow disease on relapse-free survival of patients treated with this regimen. * Compare the effects of short-term (2-hour intravenous) vs prolonged (subcutaneous release) daily GM-CSF on granulocyte activation, in order to establish the optimal route for tumor-cell kill in these patients. OUTLINE: This is an open-label study. Patients are stratified according to evaluable disease (yes \[primary refractory bone marrow disease\] vs no \[no evidence of disease\]). Patients receive sargramostim (GM-CSF) subcutaneously on days -5 to 4 and monoclonal antibody 3F8 IV over 0.5-1.5 hours on days 0-4. Treatment repeats every 3 weeks for 4 courses and then every 8 weeks for up to a total of 24 months in the absence of disease progression or unacceptable toxicity. Beginning after 2 courses of GM-CSF and monoclonal antibody 3F8, patients also receive oral isotretinoin twice daily on days 1-14 (when no monoclonal antibody 3F8 is administered). Treatment with isotretinoin repeats approximately every 28 days for 6 courses. PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.

Official TitlePhase II Study of Anti-GD2 3F8 Antibody and GM-CSF for High-Risk Neuroblastoma 
NCT00072358
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

291 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroblastomaNeuroectodermal TumorsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, Neuroepithelial

Criteria

DISEASE CHARACTERISTICS: * Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine catecholamine levels * Disease must meet risk-related treatment guidelines and any of the following International Neuroblastoma Staging System stages: * Stage 4 with (any age) OR without (\> 18 months of age of age) MYCN amplification * MYCN-amplified other than stage 1 * No evidence of disease (i.e., in complete response/remission or very good partial response/remission) OR disease resistant to standard therapy (i.e., incomplete response in bone marrow) * No progressive disease or MIBG-avid soft tissue tumor PATIENT CHARACTERISTICS: * No existing renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3 * No human anti-mouse antibody (HAMA) titer greater than 1,000 Elisa units/mL * No history of allergy to mouse proteins * No active life-threatening infection * Not pregnant * Negative pregnancy test PRIOR CONCURRENT THERAPY: * Not specified

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This phase II trial of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response of minimal residual disease (MRD) in patients with high-risk neuroblastoma (NB) and help establish the optimal way to use GM-CSF.

Group II

Experimental
This phase II trial of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response of minimal residual disease (MRD) in patients with high-risk neuroblastoma (NB) and help establish the optimal way to use GM-CSF.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Memorial Sloan-Kettering Cancer Center

New York, United StatesSee the location
CompletedOne Study Center