A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-23

Study Completion Date

2025-09-29

Brief Summary

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The purpose of this study is to test see the combined effects of the study drug called Humanized 3F8 (Hu3F8) when used with granulocyte-macrophage colony stimulating factor (GM-CSF). Hu3F8 plus GM-CSF could prevent your neuroblastoma from growing, but it could also cause side effects.

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Detailed Description

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Conditions

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Neuroblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

In this phase II single arm trial, patients with HR-NB in first CR or VGPR undergo consolidation by using hu3F8/GM-CSF.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hu3F8/GM-CSF Plus Isotretinoin

In this phase II single arm trial, patients with HR-NB in first CR or VGPR undergo consolidation by using hu3F8/GM-CSF x5 cycles and isotretinoin x6 cycles. Isotretinoin starts after cycle 2 of hu3F8/GM-CSF.

Group Type EXPERIMENTAL

Hu3F8

Intervention Type BIOLOGICAL

Day 1: hu3F8 infused iv over \~30 to 90 minutes. Day 3: hu3F8 infused iv over \~30 to 90 minutes. Day 5: hu3F8 infused iv over \~30 to 90 minutes.

GM-CSF

Intervention Type DRUG

Days -4 to 0: GM-CSF 250 mcg/m2/day, subcutaneously. Days 1 to 5: GM-CSF 500 mcg/m2/day, subcutaneously.

Isotretinoin

Intervention Type DRUG

Isotretinoin is administered at 160 mg/m2/d, divided into two doses, x14 days.

Interventions

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Hu3F8

Day 1: hu3F8 infused iv over \~30 to 90 minutes. Day 3: hu3F8 infused iv over \~30 to 90 minutes. Day 5: hu3F8 infused iv over \~30 to 90 minutes.

Intervention Type BIOLOGICAL

GM-CSF

Days -4 to 0: GM-CSF 250 mcg/m2/day, subcutaneously. Days 1 to 5: GM-CSF 500 mcg/m2/day, subcutaneously.

Intervention Type DRUG

Isotretinoin

Isotretinoin is administered at 160 mg/m2/d, divided into two doses, x14 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of NB as defined by a) histopathology (confirmed by the MSK Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
* Patients must have high-risk NB (MYCN-amplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients greater than 18 months of age).
* Patients must be in first CR/VGPR
* Patients must have a negative human anti-hu3F8 antibody (HAHA) titer

Exclusion Criteria

* Existing major organ dysfunction, i.e., renal., cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3, with the exception of hearing loss and hematologic toxicity.
* Active life-threatening infection.
* Inability to comply with protocol requirements

Eligible Sex

ALL

Accepts Healthy Volunteers

No