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.
Active, not recruiting
Early Phase 1
| Drug | Synonyms | Arms |
|---|---|---|
| Irinotecan | Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) | |
| temozolomide | Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) | |
| Hu3F8 | Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) | |
| GM-CSF | Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) | Experimental | Each cycle consists of four doses of hu3F8, five doses each of irinotecan and temozolomide and five doses of GM-CSF. |
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | N/A |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| 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. |
| Phase: | Early Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
July 22, 2021
