Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002560

Purpose

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.

Condition	Intervention	Phase
Neuroblastoma	Biological: monoclonal antibody 3F8 Biological: sargramostim	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA

Resource links provided by NLM:

MedlinePlus related topics: Cancer Neuroblastoma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	40
Study Start Date:	February 1994

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.

Eligibility

Ages Eligible for Study:	2 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002560

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Study Chair:

Brian H. Kushner, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000063466, MSKCC-94018, NCI-V94-0416
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002560 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent neuroblastoma

Additional relevant MeSH terms:

Neuroectodermal Tumors, Primitive
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Pharmacologic Actions
Neuroblastoma
Antibodies, Monoclonal

Neuroectodermal Tumors
Neoplasms
Antibodies
Neoplasms, Germ Cell and Embryonal
Neoplasms, Neuroepithelial
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial
Immunoglobulins

ClinicalTrials.gov processed this record on November 30, 2009