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Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma

Phase I/II Study of Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma

NCT01757626•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out if an antibody called Humanized 3F8 (Hu3F8) combined with granulocyte- macrophage colony stimulating factor (GM-CSF) is safe for treating neuroblastoma.

Eligibility

Age

1 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
•Patients must have high-risk NB (including MYCNamplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients greater than 18 months of age) AND:
•Phase I: Patients must have refractory or relapsed NB, resistant to standard therapy\*.
•\*For NB, standard therapy includes intensive induction chemotherapy, followed by a variety of consolidation or salvage therapies, depending on response.
•Phase II: Patients must have primary or secondary refractory disease in BM, defined as morphologic evidence of NB in BM and/or abnormal 123I-MIBG uptake in osteomedullary sites, OR patients patients in ≥ 2nd CR patients are in ≥2nd CR
•Patients must be older than 1 year of age.
•Prior treatment with murine and humanized 3F8 is allowed. Patients with prior m3F8, hu3F8, ch14.18 or hu14.18 treatment must have a negative HAHA antibody titer. Human anti-mouse antibody (HAMA) positivity is allowed.
•White blood cell count ≥1000/ul (phase I only)
•Absolute neutrophil count ≥500/ul (phase I only)
•Absolute lymphocyte count ≥500/ul (phase I only)
+4 more criteria

Exclusion Criteria

•Existing major organ dysfunction \> grade 2, with the exception of hearing loss and hematologic toxicity (defined as suppression of all subtypes of WBCs, RBCs, and platelets).
•Active life-threatening infection.
•Pregnant women or women who are breast-feeding.
•Inability to comply with protocol requirements, including PK studies and genetic studies (phase I only)
•History of allergy to mouse proteins.
•Positive human anti-hu3F8 antibody (HAHA) titer

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

December 1, 2012

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

January 7, 2026

Enrollment

186

ACTUAL participants

Conditions

Neuroblastoma

Interventions

Hu3F8 With GM-CSF

BIOLOGICAL

Hu3F8 With GM-CSF

BIOLOGICAL

A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma

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Neuroblastoma

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Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

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NeuroblastomaEwing Sarcoma+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma

Inclusion Criteria

Exclusion Criteria

A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

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