Neuroblastoma (NB) Clinical Trial
Official title:
Phase II Study of Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) Chemoimmunotherapy for High-Risk Neuroblastoma
| Verified date | September 2023 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 48 |
| Est. completion date | June 2024 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center | Y-mAbs Therapeutics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 |