Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma
NCT ID: NCT00002560
Last Updated: 2013-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
1994-02-28
2005-04-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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monoclonal antibody 3F8
sargramostim
Eligibility Criteria
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Inclusion Criteria
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
2 Years
21 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Principal Investigators
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Brian H. Kushner, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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CDR0000063466
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-V94-0416
Identifier Type: -
Identifier Source: secondary_id
94-018
Identifier Type: -
Identifier Source: org_study_id
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