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

Memorial Sloan Kettering Cancer Center4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuroblastoma

Interventions

3F8 monoclonal antibody and 13-cis-Retinoic AcidDRUG

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.

Eligibility

Sex: ALLMin age: 18 Months

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 2 years

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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