3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neuroblastoma
1 other identifier
interventional
39
1 country
1
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. Antibodies are made by the body to attack tumors and to fight infections. 3F8 is the name of one kind of antibody. It is made by mice, and it can attack neuroblastoma in people. 3F8 has been used safely in many patients, and it has killed cancer cells in some patients. One way it can kill cancer cells is by causing the patient's own white blood cells to attack the cancer. Granulocytes are one kind of white blood cell. GM-CSF increases the number of granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2010
CompletedFirst Submitted
Initial submission to the registry
August 16, 2010
CompletedFirst Posted
Study publicly available on registry
August 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2018
CompletedResults Posted
Study results publicly available
August 13, 2019
CompletedAugust 13, 2019
April 1, 2019
8.1 years
August 16, 2010
July 24, 2019
July 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess the Impact of High-dose 3F8/GM-CSF
on relapse-free survival in patients in first complete or very good partial remission, but at high risk of relapse.
2 years
Secondary Outcomes (2)
Apply Real-time Quantitative RT-PCR
2 years
Monitor Safety of the High-dose Antibody Treatment
2 years
Study Arms (1)
3F8 and 13-cis-retinoic acid
EXPERIMENTALThis 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(8), patients no longer receive high dose 3F8 but receive only standard dose 3F8 (20mg/m2/day) for all cycles.
Interventions
3F8 is dosed at 80 mg/m2/day (cycles 1-2) or 20 mg/m2/day (cycles 3 and beyond) and infused iv over 30-90 minutes. 13-cis-retinoic acid is dosed at 160 mg/m2/day, divided into two doses, x14 days. If a dose is missed, it can be made up at the end of the cycle. It is not taken on same days as 3F8. \*High-dose 3F8 will be administered only for patients enrolled on protocol from A(0) to A(7). Starting with A(8), patients receive standard dose (20mg/m2/day) during cycles 1 and 2.
Eligibility Criteria
You may qualify if:
- 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 (≥18 months of age) MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified stage 4S.
- The patients are in first CR/VGPR after conventional therapy. They have no measurable MIBG-avid soft tissue tumor assessable for response.
- Signed informed consent indicating awareness of the investigational nature of this program.
You may not qualify if:
- 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 v3.0) 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (1)
Kushner BH, Modak S, Basu EM, Roberts SS, Kramer K, Cheung NK. Posterior reversible encephalopathy syndrome in neuroblastoma patients receiving anti-GD2 3F8 monoclonal antibody. Cancer. 2013 Aug 1;119(15):2789-95. doi: 10.1002/cncr.28137. Epub 2013 Apr 30.
PMID: 23633099DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brian Kushner, MD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Kushner, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2010
First Posted
August 17, 2010
Study Start
August 12, 2010
Primary Completion
September 13, 2018
Study Completion
September 13, 2018
Last Updated
August 13, 2019
Results First Posted
August 13, 2019
Record last verified: 2019-04