Phase 2 N=4 Treatment

High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Myeloablative Therapy and Autologous Stem-Cell Transplantation

Neuroblastoma

Bottom Line

View on ClinicalTrials.gov: NCT01183416 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Oct 2019

Primary outcome: Primary: Assess the Impact of High-dose 3F8/GM-CSF on Relapse-free Survival

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 3F8 monoclonal antibody and 13-cis-Retinoic Acid (Drug)
Age: Pediatric, Adult, Older Adult · 0+ yrs
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Assess the Impact of High-dose 3F8/GM-CSF on Relapse-free Survival	—	—
SECONDARY Apply Real-time Quantitative RT-PCR to Test the Hypothesis That the Minimal Residual Disease Content of Bone Marrow	—	—
SECONDARY Monitor Safety of the High-dose Antibody Treatment	—	—

Summary

The purpose of this study is to see if high-dose 3F8 combined with GM-CSF is better than standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out what effects, good and/or bad, 3F8 has on cancer. The investigators also want to see if the antibody works against a very small amount of neuroblastoma (minimal residual disease) that is left in the bone marrow.

Eligibility Criteria

Inclusion Criteria

Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
High-risk NB as defined by risk-related treatment guidelines1 and the International NB Staging System,89 i.e., stage 4 with (any age) or without (> or = to 18 months of age) MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified stage 4S.
The patients are post-stem cell transplantation and in first CR/VGPR, including no measurable MIBG-avid soft tissue tumor assessable for response.
Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria

Creatinine > 3.0 mg/dL
ALT, AST and Alkaline Phosphatase > 5.0 times the upper limit of normal
Bilirubin > 3.0 mg/dL
Patients with grade 3 or higher toxicities (using the CTCAE v3.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam. Patients must have normal blood pressure for age.
Progressive disease
History of allergy to mouse proteins.
Active life-threatening infection.
Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml.
Inability to comply with protocol requirements

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01183416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.