3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma

Phase 2

Terminated

• Conditions: Neuroblastoma
• Interventions: Biological: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid

• Registration Number: NCT01183884
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-17
• Study First Posted: 2010-08-18
• Status Verified: 2018-09
• Primary Completion: 2018-11-09
• Study Completion: 2018-11-09
• Results First Submitted: 2019-10-25
• Results First Submitted QC: 2019-11-12
• Last Update Submitted: 2019-11-12
• Results First Posted: 2019-11-14
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid	3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid	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.

Primary Outcome Measures

Name	Time	Method
Assess the Impact of High-dose 3F8/GM-CSF on Relapse-free Survival	2 years	in patients in second or greater complete or very good partial remission, but at high risk of additional relapse.

Secondary Outcome Measures

Name	Time	Method
Apply Real-time Quantitative RT-PCR to Test the Hypothesis That the Minimal Residual Disease Content of Bone Marrow	2 years	after the first treatments with 3F8/GMCSF has significant prognostic impact on relapse-free survival.
Monitor Safety of the High-dose Antibody Treatment	2 years	to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States