Overview

This trial is active, not recruiting.

Condition neuroblastoma
Treatment 3f8/gm-csf immunotherapy plus 13-cis-retinoic acid
Phase phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Start date August 2010
End date August 2017
Trial size 63 participants
Trial identifier NCT01183884, 09-160

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles. Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles.
3f8/gm-csf immunotherapy plus 13-cis-retinoic acid
3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles .Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles. The patients are in > or = to 2nd CR/VGPR and at high risk for additional relapse. Real-time quantitative RT-PCR63-65 will be used to assess MRD in BM. 13-cis-retinoic acid is started after cycle 2.

Primary Outcomes

Measure
Assess the impact of high-dose 3F8/GM-CSF on relapse-free survival
time frame: 2 years

Secondary Outcomes

Measure
Apply real-time quantitative RT-PCR to test the hypothesis that the minimal residual disease content of bone marrow
time frame: 2 years
Monitor safety of the high-dose antibody treatment
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 months old.

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 in >2nd 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 v34.0) 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.

Additional Information

Official title 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma: A Phase II Study
Principal investigator Brian Kushner, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.