Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00002560
First received: November 1, 1999
Last updated: June 27, 2013
Last verified: June 2013
  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 2

Study Type: Interventional
Study Design: Primary Purpose: 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:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 40
Study Start Date: February 1994
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

ClinicalTrials.gov Identifier: NCT00002560     History of Changes
Other Study ID Numbers: 94-018, CDR0000063466, NCI-V94-0416
Study First Received: November 1, 1999
Last Updated: June 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
recurrent neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014