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

Neuroblastoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01183884
• Other study ID #: 09-160
• Status: Terminated
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: November 9, 2018

Study information

• Verified date: September 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the Impact of High-dose 3F8/GM-CSF on Relapse-free Survival	in patients in second or greater complete or very good partial remission, but at high risk of additional relapse.	2 years
Secondary	Apply Real-time Quantitative RT-PCR to Test the Hypothesis That the Minimal Residual Disease Content of Bone Marrow	after the first treatments with 3F8/GMCSF has significant prognostic impact on relapse-free survival.	2 years
Secondary	Monitor Safety of the High-dose Antibody Treatment	to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.	2 years

External Links

•   Memorial Sloan-Kettering Cancer Center