Monoclonal Antibody Therapy in Treating Children With Metastatic Neuroblastoma in Second Remission

This study is ongoing, but not recruiting participants.

First Received: November 1, 1999 Last Updated: February 6, 2009 History of Changes

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002458

Purpose

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating children with metastatic neuroblastoma in second remission.

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

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase II Study of Adjuvant Therapy With Antiganglioside GD2-Specific Mouse Monoclonal Antibody 3F8 for Metastatic Neuroblastoma in Second Remission

Resource links provided by NLM:

MedlinePlus related topics: Cancer Neuroblastoma

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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

Study Start Date:

November 1987

Detailed Description:

OBJECTIVES: I. Evaluate the efficacy of ganglioside GD2-specific monoclonal antibody 3F8 as adjuvant therapy in patients with Stage IV neuroblastoma in second remission.

OUTLINE: Biological Response Modifier Therapy. Antiganglioside GD2-specific Monoclonal Antibody 3F8, MOAB 3F8.

PROJECTED ACCRUAL: A maximum of 20 patients will be entered.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, Stage IV neuroblastoma in second or subsequent complete remission, defined by the complete disappearance of all evidence of tumor on the following: Physical examination Second-look surgery Bone scan Bone marrow aspiration and biopsy Chest x-ray CT MIBG Urinary catecholamines If marrow is infiltrated by tumor, complete elimination of tumor cells from the marrow compartment must be demonstrated by histology and immunofluorescence (based on simultaneous bone marrow aspiration and biopsy samples from at least 4 separate sites)

PATIENT CHARACTERISTICS: Age: Under 18 Performance status: Not specified Life expectancy: Greater than 12 weeks Hematopoietic: Grade 4 cytopenias allowed Grade 3 marrow hypoplasia allowed Hepatic: Not specified Renal: No renal dysfunction worse than grade 3 Cardiovascular: No cardiac dysfunction worse than grade 2 Pulmonary: No pulmonary dysfunction worse than grade 2 Other: No neurologic dysfunction worse than grade 2 Hearing deficit allowed

PRIOR CONCURRENT THERAPY: Prior murine antibody therapy allowed provided circulating HAMA titer is less than 1,000 U/mL serum by ELISA

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002458

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:

Nai-Kong V. Cheung, MD, PhD

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:	CDR0000075103, MSKCC-87118, NCI-V88-0357
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002458 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

disseminated neuroblastoma
recurrent neuroblastoma

Study placed in the following topic categories:

Neuroectodermal Tumors, Primitive
Immunologic Factors
Adjuvants, Immunologic
Neuroblastoma
Recurrence
Antibodies, Monoclonal
Neuroectodermal Tumors

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

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

ClinicalTrials.gov processed this record on September 01, 2009