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Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma - Article


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Clinical Trial: Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

This study has been suspended.

Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
recurrent neuroblastoma
 Drug: monoclonal antibody 3F8
 Drug: sargramostim
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: monoclonal antibody therapy
Phase II

MedlinePlus related topics:  Neuroblastoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Monoclonal Antibody 3F8 with Sargramostim (GM-CSF) in Patients with Advanced Neuroblastoma

Further Study Details: 

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   -   21 Years,  Genders Eligible for Study:  Both

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:

Pulmonary:

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

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Location Information


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

Study chairs or principal investigators

Brian H. Kushner, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000063466; MSKCC-94018; NCI-V94-0416
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002560
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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November 26, 2009



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