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Clinical Trial: Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma
This study has been suspended.
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
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:
- 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
Location Information
Brian H. Kushner, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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
Resources
- Body work (Wikipedia)
- Massage therapy (Wikipedia)

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