Study of Chemoimmunotherapy for High-Risk Neuroblastoma

Conditions

• Neuroblastoma (NB)

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Irinotecan — DRUG
  50mg/m\^2/day IV will be administered from day 1-5
• temozolomide — DRUG
  (given concurrently with Irinotecan) 150mg/m\^2/day orally
• Hu3F8 — BIOLOGICAL
  2.25mg/kg IV will be administered on days 2, 4, 8 and 10
• GM-CSF — DRUG
  250mcg/m2/day SC will be administered on days 6-10

Study Details

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.

Key Dates

Start date

Jun 12, 2017

Status verified

Jul 2025

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

48 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 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.

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]

Locations (1)

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