Phase 2 N=39 Treatment

3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neuroblastoma

Neuroblastoma

Bottom Line

View on ClinicalTrials.gov: NCT01183429 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2019

Primary outcome: Primary: Assess the Impact of High-dose 3F8/GM-CSF

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Assess the Impact of High-dose 3F8/GM-CSF	—	—
SECONDARY Apply Real-time Quantitative RT-PCR	—	—
SECONDARY Monitor Safety of the High-dose Antibody Treatment	—	—

Summary

The purpose of this study is to find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer. Antibodies are made by the body to attack tumors and to fight infections. 3F8 is the name of one kind of antibody. It is made by mice, and it can attack neuroblastoma in people. 3F8 has been used safely in many patients, and it has killed cancer cells in some patients. One way it can kill cancer cells is by causing the patient's own white blood cells to attack the cancer. Granulocytes are one kind of white blood cell. GM-CSF increases the number of granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.

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 (≥18 months of age) MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified stage 4S.
The patients are in first CR/VGPR after conventional therapy. They have 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 (NCT01183429). 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.