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Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuroblastoma

Intervention: anti-GD2 murine IgG3 monoclonal antibody 3F8 (Biological); anti-GD2 murine IgG3 monoclonal antibody 3F8 (Biological)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Brian H. Kushner, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center


RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Combining monoclonal antibody 3F8 with sargramostim may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with sargramostim in treating patients who have neuroblastoma.

Clinical Details

Official title: Phase II Study of Anti-GD2 3F8 Antibody and GM-CSF for High-Risk Neuroblastoma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Efficacy at completion of treatment

Relapse-free survival every 3 months

Secondary outcome:

Compare granulocyte activation in patients treated with short-term vs prolonged daily exposure to sargramostim (GM-CSF) after 4 courses

Simplify treatment with consequent reduction in cost

Detailed description: OBJECTIVES:

- Determine the efficacy of sargramostim (GM-CSF) in enhancing monoclonal antibody

3F8-mediated ablation in patients with high-risk neuroblastoma.

- Determine the prognostic impact of minimal residual bone marrow disease on relapse-free

survival of patients treated with this regimen.

- Compare the effects of short-term (2-hour intravenous) vs prolonged (subcutaneous

release) daily GM-CSF on granulocyte activation, in order to establish the optimal route for tumor-cell kill in these patients. OUTLINE: This is an open-label study. Patients are stratified according to evaluable disease (yes [primary refractory bone marrow disease] vs no [no evidence of disease]).

Patients receive sargramostim (GM-CSF) subcutaneously on days - 5 to 4 and monoclonal

antibody 3F8 IV over 0. 5-1. 5 hours on days 0-4. Treatment repeats every 3 weeks for 4 courses and then every 8 weeks for up to a total of 24 months in the absence of disease progression or unacceptable toxicity. Beginning after 2 courses of GM-CSF and monoclonal antibody 3F8, patients also receive oral isotretinoin twice daily on days 1-14 (when no monoclonal antibody 3F8 is administered). Treatment with isotretinoin repeats approximately every 28 days for 6 courses. PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.



- Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine

catecholamine levels

- Disease must meet risk-related treatment guidelines and any of the following

International Neuroblastoma Staging System stages:

- Stage 4 with (any age) OR without (> 18 months of age of age) MYCN amplification

- MYCN-amplified other than stage 1

- No evidence of disease (i. e., in complete response/remission or very good partial

response/remission) OR disease resistant to standard therapy (i. e., incomplete response in bone marrow)

- No progressive disease or MIBG-avid soft tissue tumor


- No existing renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal

toxicity ≥ grade 3

- No human anti-mouse antibody (HAMA) titer greater than 1,000 Elisa units/mL

- No history of allergy to mouse proteins

- No active life-threatening infection

- Not pregnant

- Negative pregnancy test


- Not specified

Locations and Contacts

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2003
Last updated: July 21, 2015

Page last updated: August 23, 2015

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