Overview

This trial is active, not recruiting.

Condition neuroblastoma
Treatment 3f8/gm-csf immunotherapy plus 13-cis-retinoic
Phase phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Start date August 2010
End date August 2017
Trial size 31 participants
Trial identifier NCT01183897, 09-161

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.

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 study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
3f8/gm-csf immunotherapy plus 13-cis-retinoic
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 (20mg/m2/day) for all cycles The patients have primary refractory BM disease. Protocol treatment is through 24 months. Real-time quantitative RT-PCR63-65 will be used to assess MRD in BM. 13-cis-retinoic acid is started no later than after cycle 4 (i.e., after response is scored), but sooner if CR is achieved after cycles 1, 2, or 3, or if early HAMA develops.

Primary Outcomes

Measure
Assess the activity of high-dose 3F8/GM-CSF
time frame: 2 years

Secondary Outcomes

Measure
Apply real-time quantitative RT-PCR
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 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.

Additional Information

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