Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

This study has been completed.

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00002560

First received: November 1, 1999

Last updated: December 13, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

December 13, 2009

Start Date ^ICMJE

February 1994

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00002560 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

Official Title ^ICMJE

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

Brief 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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Neuroblastoma

Intervention ^ICMJE

Biological: monoclonal antibody 3F8
Biological: sargramostim

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00002560

Other Study ID Numbers ^ICMJE

CDR0000063466, MSKCC-94018, NCI-V94-0416

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Brian H. Kushner, MD

Memorial Sloan-Kettering Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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