Study of Chemoimmunotherapy for High-Risk Neuroblastoma

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Study of Chemoimmunotherapy for High-Risk Neuroblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03189706
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial Sloan Kettering Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Shakeel Modak, MD
Principal Investigator Affiliation	Memorial Sloan Kettering Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroblastoma (NB)
Study Website:	View Trial Website

Arms & Interventions

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.

Interventions

Drug: - Irinotecan

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

Drug: - temozolomide

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

Biological: - Hu3F8

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

Drug: - GM-CSF

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065