Clinical Trials /

Study of Chemoimmunotherapy for High-Risk Neuroblastoma

NCT03189706

Description:

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.

Related Conditions:
  • Neuroblastoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of Chemoimmunotherapy for High-Risk Neuroblastoma
  • Official Title: Phase II Study of Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) Chemoimmunotherapy for High-Risk Neuroblastoma

Clinical Trial IDs

  • ORG STUDY ID: 17-251
  • NCT ID: NCT03189706

Conditions

  • Neuroblastoma (NB)

Interventions

DrugSynonymsArms
IrinotecanHu3F8, Irinotecan/Temozolomide and Sargramostim (HITS)
temozolomideHu3F8, Irinotecan/Temozolomide and Sargramostim (HITS)
Hu3F8Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS)
GM-CSFHu3F8, Irinotecan/Temozolomide and Sargramostim (HITS)

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.

Trial Arms

NameTypeDescriptionInterventions
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.
  • Irinotecan
  • temozolomide
  • Hu3F8
  • GM-CSF

Eligibility 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 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame:2 years
Safety Issue:
Description: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.

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Hu3F8
  • Irinotecan
  • Temozolomide
  • Sargramostim
  • Chemoimmunotherapy
  • 17-251

Last Updated

December 2, 2019