Study of Chemoimmunotherapy for 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

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-12

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this study is to find out whether an experimental drug called Hu3F8 can be given with the chemotherapy drugs irinotecan and temozolomide and another drug called GM-CSF. The investigators want to find out if this combination is safe and what effect it has on the participant and the disease.

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Detailed Description

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Conditions

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Neuroblastoma (NB)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a pilot study of HITS in patients with resistant NB.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS)

Each cycle consists of four doses of hu3F8, five doses each of irinotecan and temozolomide and five doses of GM-CSF.

Group Type EXPERIMENTAL

Irinotecan

Intervention Type DRUG

50mg/m\^2/day IV will be administered from day 1-5

temozolomide

Intervention Type DRUG

(given concurrently with Irinotecan) 150mg/m\^2/day orally

Hu3F8

Intervention Type BIOLOGICAL

2.25mg/kg IV will be administered on days 2, 4, 8 and 10

GM-CSF

Intervention Type DRUG

250mcg/m2/day SC will be administered on days 6-10

Interventions

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Irinotecan

50mg/m\^2/day IV will be administered from day 1-5

Intervention Type DRUG

temozolomide

(given concurrently with Irinotecan) 150mg/m\^2/day orally

Intervention Type DRUG

Hu3F8

2.25mg/kg IV will be administered on days 2, 4, 8 and 10

Intervention Type BIOLOGICAL

GM-CSF

250mcg/m2/day SC will be administered on days 6-10

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of NB as defined by international criteria,.e., histopathology (confirmed by the MSK Department of Pathology) or bone marrow metastases plus high urine catecholamine levels
* High-risk NB as defined as any of the following:

* Stage 4 with MYCN amplification (any age)
* Stage 4 without MYCN amplification (\>1.5 years of age)
* Stage 3 with MYCN amplification (unresectable; any age)
* Stage 4S with MYCN amplification (any age)
* Patients fulfill one of the following criteria:

1. Have evidence of soft tissue disease OR
2. If they only have osteomedullary disease at protocol enrollment, they should have:

* Had previously received Hu3F8+GMCSF therapy AND have had less than a complete response to it OR
* Had progressed progressive disease after their most recent anti-neuroblastoma therapeutic regimen
* Patients must have evaluable (microscopic marrow metastasis, elevated tumor markers, positive MIBG or PET scans) or measurable (CT, MRI) disease documented after completion of prior systemic therapy.
* Prior treatment with murine and hu3F8 is allowed.
* Prior treatment with irinotecan or temozolomide is permitted.
* Patients with prior m3F8, hu3F8, ch14.18 or hu14.18 treatment must have a negative HAHA antibody titer. Human anti-mouse antibody positivity is allowed.
* Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria

* Patients with CR/VGPR disease
* Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3 except for hearing loss, alopecia, anorexia, nausea, and hypomagnesemia from TPN, which may be grade 3
* ANC \< 500/uL
* Platelet count \<30K/uL
* History of allergy to mouse proteins
* Active life-threatening infection
* Inability to comply with protocol requirements
* Women who are pregnant or breast-feeding

Eligible Sex

ALL

Accepts Healthy Volunteers

No