Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• Not specified

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

Brian H. Kushner

Principal Investigator

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Brian H. Kushner	Ph: 212-639-6793
			Email: kushnerb@mskcc.org

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00072358
Information obtained from ClinicalTrials.gov on February 06, 2012

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