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Study of Chemoimmunotherapy for High-Risk Neuroblastoma

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ClinicalTrials.gov Identifier: NCT03189706
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Y-Mabs, Inc
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Neuroblastoma (NB) Drug: Irinotecan Drug: temozolomide Biological: Hu3F8 Drug: GM-CSF Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pilot study of HITS in patients with resistant NB.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) Chemoimmunotherapy for High-Risk Neuroblastoma
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
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.
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
250mg/m2/day SC will be administered on days 6-10




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]
    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. response rate (CR+PR) [ Time Frame: 2 years ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 previously received Hu3F8+GMCSF therapy AND have had progressed while receiving it or had an incomplete response
  • 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 HAHA antibody titer ≤1300 Elisa units/ml. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189706


Contacts
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Contact: Shakeel Modak, MD 212-639-7623 modaks@mskcc.org
Contact: Brian Kushner, MD 212-639-6793

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Shakeel Modak, MD    212-639-7623      
Contact: Brian Kushner, MD    212-639-6793      
Principal Investigator: Shakeel Modak         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Y-Mabs, Inc
Investigators
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Principal Investigator: Shakeel Modak, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03189706     History of Changes
Other Study ID Numbers: 17-251
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Hu3F8
Irinotecan
Temozolomide
Sargramostim
Chemoimmunotherapy
17-251

Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Irinotecan
Temozolomide
Sargramostim
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Immunologic Factors
Physiological Effects of Drugs