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

November 1, 1999
June 27, 2013
February 1994
April 2005   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00002560 on ClinicalTrials.gov Archive Site
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Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma
PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Neuroblastoma
  • Biological: monoclonal antibody 3F8
  • Biological: sargramostim
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2005
April 2005   (final data collection date for primary outcome measure)

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
Both
2 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002560
94-018, CDR0000063466, NCI-V94-0416
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Memorial Sloan-Kettering Cancer Center
Not Provided
Study Chair: Brian H. Kushner, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2013

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