Study of Chemoimmunotherapy for High-Risk Neuroblastoma
Phase II Study of Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) Chemoimmunotherapy for High-Risk Neuroblastoma
1 other identifier
interventional
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jun 2017
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2017
CompletedFirst Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedJuly 2, 2025
July 1, 2025
9 years
June 13, 2017
July 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The regimen will be considered safe if there are no toxicities requiring discontinuation of therapy in at least 9/10 patients during the first two cycles.
2 years
response rate (CR+PR)
Response assessment will be based on the best response over the course of four cycles. Disease response for NB will use the International NB Response Criteria. Patients who withdraw from the study prior to cycle 4 with \< partial response will also not be considered evaluable for response and will be replaced.
2 years
Study Arms (1)
Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS)
EXPERIMENTALEach cycle consists of four doses of hu3F8, five doses each of irinotecan and temozolomide and five doses of GM-CSF.
Interventions
50mg/m\^2/day IV will be administered from day 1-5
(given concurrently with Irinotecan) 150mg/m\^2/day orally
2.25mg/kg IV will be administered on days 2, 4, 8 and 10
250mcg/m2/day SC will be administered on days 6-10
Eligibility Criteria
You may qualify if:
- 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:
- Have evidence of soft tissue disease OR
- 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.
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Y-mAbs Therapeuticscollaborator
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shakeel Modak, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 16, 2017
Study Start
June 12, 2017
Primary Completion
June 1, 2026
Study Completion
June 1, 2026
Last Updated
July 2, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.