Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-… (NCT01757626) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Combination Therapy of Antibody Hu3F8 With Granulocyte- Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Relapsed/Refractory High-Risk Neuroblastoma
United States186 participantsStarted 2012-12
Plain-language summary
The purpose of this study is to find out if an antibody called Humanized 3F8 (Hu3F8) combined with granulocyte- macrophage colony stimulating factor (GM-CSF) is safe for treating neuroblastoma.
Who can participate
Age range1 Year
SexALL
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Inclusion Criteria:
* Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
* Patients must have high-risk NB (including MYCNamplified stage 2/3/4/4S of any age and MYCN-nonamplified stage 4 in patients greater than 18 months of age) AND:
* Phase I: Patients must have refractory or relapsed NB, resistant to standard therapy\*.
\*For NB, standard therapy includes intensive induction chemotherapy, followed by a variety of consolidation or salvage therapies, depending on response.
* Phase II: Patients must have primary or secondary refractory disease in BM, defined as morphologic evidence of NB in BM and/or abnormal 123I-MIBG uptake in osteomedullary sites, OR patients patients in ≥ 2nd CR patients are in ≥2nd CR
* Patients must be older than 1 year of age.
* Prior treatment with murine and humanized 3F8 is allowed. Patients with prior m3F8, hu3F8, ch14.18 or hu14.18 treatment must have a negative HAHA antibody titer. Human anti-mouse antibody (HAMA) positivity is allowed.
* White blood cell count ≥1000/ul (phase I only)
* Absolute neutrophil count ≥500/ul (phase I only)
* Absolute lymphocyte count ≥500/ul (phase I only)
* Platelet count ≥25,000/ul (phase I only)
* No chemotherapy or immunotherapy for a minimum of three weeks prior to start of hu3F8
* Women of child-bearing potential must be willing to practice an effective method of birth control whil…