Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

Neuroblastoma Clinical Trial

Official title:

PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002560
• Other study ID #: 94-018
• Secondary ID: CDR0000063466NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 27, 2013
• Start date: February 1994
• Est. completion date: April 2005

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.

Description:

OBJECTIVES:

• Define the antitumor effects of monoclonal antibody 3F8/sargramostim (3F8/GM-CSF) in patients with advanced neuroblastoma.

• Assess the biological effects of 3F8/GM-CSF in these patients.

OUTLINE: Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 11-40 patients will be accrued for this study over 4 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 21 Years

Eligibility

DISEASE CHARACTERISTICS:

• Neuroblastoma diagnosed by INSS criteria, i.e., either:

• Histologic proof of disease OR

• Tumor clumps in bone marrow plus elevated catecholamine levels

• Relapsed disease with poor long-term prognosis as indicated by at least one of the following:

• N-myc amplification in tumor cells

• Diploid chromosomal content in tumor cells

• Distant skeletal metastases

• Unresectable primary tumor crossing the midline

• Bone marrow with greater than 10% tumor cells

• Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required

• No rapidly progressive disease

• Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols

PATIENT CHARACTERISTICS:

Age:

• 2 to 21

Performance status:

• Not specified

Life expectancy:

• Greater than 8 weeks

Hematologic:

• Not specified

Hepatic:

• No grade 3/4 toxicity

• LDH no greater than 1.5 times upper limit of normal

Renal:

• Creatinine clearance at least 60 mL/min

• No grade 3/4 toxicity

Cardiovascular:

• No grade 3/4 toxicity

Pulmonary:

• No grade 3/4 toxicity

Other:

• No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit

• No active life threatening infections

• No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL

• No allergy to mouse proteins

• No pain requiring opiates

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Biological:
• monoclonal antibody 3F8

• sargramostim

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,