High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Myeloablative Therapy and Autologous Stem-Cell Transplantation

Neuroblastoma Clinical Trial

Official title:

High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Myeloablative Therapy and Autologous Stem-Cell Transplantation in Patients With High-Risk Neuroblastoma: A Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183416
• Other study ID #: 09-158
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: October 31, 2018

Study information

• Verified date: October 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 see if high-dose 3F8 combined with GM-CSF is better than standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out what effects, good and/or bad, 3F8 has on cancer. The investigators also want to see if the antibody works against a very small amount of neuroblastoma (minimal residual disease) that is left in the bone marrow.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 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 post-stem cell transplantation and in first 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 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

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• 3F8 monoclonal antibody and 13-cis-Retinoic Acid
A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are ~6-8 weeks. 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 who are post-stem-cell transplantation and in first complete or very good partial remission, but at high risk of 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