Status:
COMPLETED
Monoclonal Antibody 3F8 and GM-CSF in Treating Young Patients With High-Risk, Refractory or Relapsed Neuroblastoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neuroblastoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
RATIONALE: Monoclonal antibodies, such as 3F8, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry t...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of monoclonal antibody 3F8 when administered with sargramostim (GM-CSF) in young patients with high-risk, refractory or relapsed neuroblastoma. * As...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of NB as defined by international criteria,45 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels.
- Patients must have refractory or relapsed high-risk NB (including MYCNamplified stage 3/4/4S and MYCN-nonamplified stage 4 \>18 months old) resistant to standard therapy.
- Prior treatment with 3F8 is allowed.
- Age \<21 years.
- Signed informed consent indicating awareness of the investigational nature of this program.
Exclusion
- Existing major organ dysfunction should be grade 2 or less, with the exception of myelosuppression (neutrophil count \>500/ul and platelet count \>10,000/ul are acceptable), alopecia, hearing loss. Patient cannot be taking antihypertensive medication.
- History of allergy to mouse proteins.
- Active life-threatening infection.
- Human anti-mouse antibody (HAMA) titer \>1000 ELISA units/ml.
- Prior treatment with 3F8 is NOT an exclusion criterion.
- Inability to comply with protocol requirements.
- Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00450307
Start Date
June 1 2005
End Date
April 1 2013
Last Update
October 16 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065