A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/7/2019
Start Date:January 23, 2017
End Date:June 2022
Contact:Brian H. Kushner, MD
Email:kushnerb@mskcc.org
Phone:212-639-6793

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Trial Summary
Trial Overview
Inclusion Criteria

Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin for Consolidation of First Remission of Patients With High-Risk Neuroblastoma: A Phase II Study

The purpose of this study is to test see the combined effects of the study drug called
Humanized 3F8 (Hu3F8) when used with granulocyte-macrophage colony stimulating factor
(GM-CSF). Hu3F8 plus GM-CSF could prevent your neuroblastoma from growing, but it could also
cause side effects.


Inclusion Criteria:

- Diagnosis of NB as defined by a) histopathology (confirmed by the MSK Department of
Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine
levels.

- Patients must have high-risk NB (MYCN-amplified stage 2/3/4/4S of any age and
MYCN-nonamplified stage 4 in patients greater than 18 months of age).

- Patients must be in first CR/VGPR

- Human anti-hu3F8 antibody (HAHA) titer >1300 Elisa unites/ml

Exclusion Criteria:

- Existing major organ dysfunction, i.e., renal., cardiac, hepatic, neurologic,
pulmonary, or gastrointestinal toxicity ≥ grade 3, with the exception of hearing loss
and hematologic toxicity.

- Active life-threatening infection.

- Inability to comply with protocol requirements
We found this trial at
1
site
Memorial Sloan Kettering Cancer Center
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Brian H. Kushner, MD
Phone: 212-639-6793
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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