Phase 2 N=31 Treatment

3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow

Neuroblastoma

Bottom Line

View on ClinicalTrials.gov: NCT01183897 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2019

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

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic (Biological)
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 Activity 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 see find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer.

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 or MYCN-amplified stage 4S.
Patients have primary refractory disease limited to BM, i.e., high-risk NB (defined above) resistant to standard therapy, as evidenced by incomplete response in BM, but no measurable MIBG-avid soft tissue tumor assessable for response and no progressive disease.
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 v 4.0) 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 (NCT01183897). 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.