Status:
COMPLETED
Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Neuroblastoma
Bone Marrow, Sympathetic Nervous System
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Funding Source - FDA OOPD FDR004128 The goal of this study is to see if it is safe and feasible to give chemotherapy, natural killer (NK) cells, and an antibody called 3F8. The NK cells must come fro...
Eligibility Criteria
Inclusion
- Diagnosis of NB as defined by international criteria, i.e., histopathology (confirmed by the MSKCC Department of Pathology) or bone marrow metastases plus high urine catecholamine levels
- High-risk NB as defined by risk-related treatment guidelines and the International NB Staging System,57 i.e., stage 4 with (any age) or without (\>365 days of age) MYCN amplification, MYCN-amplified stage 3 (unresectable; any age), or MYCN-amplified stage 4S.
- Patients must have a history of tumor progression or persistent disease or failure to achieve complete response following standard therapy.
- Patients must have evaluable (microscopic marrow metastasis, elevated tumor markers, positive MIBG or PET scans) or measurable (CT, MRI) disease documented after completion of prior systemic therapy.
- Disease staging approximately within one month of treatment.
- Human anti-mouse antibody (HAMA) titer \<1000 Elisa units/ml if applicable
- Available autologous stem cells: ≥2 x 106 CD34+ cells/kg
- Adequate cardiac function as measured by echocardiogram
- Eligible NK donor
- Signed informed consent indicating awareness of the investigational nature of this program.
- Donor Eligibility
- Donor is blood-related and HLA-haploidentical to the recipient.
- Donor has undergone serologic testing for transmissible diseases as per blood banking guidelines for organ and tissue donors. Tests include but are not limited to: HepBsAg, HepBsAb, HepBcAb, HepC antibody, HIV, HTLV I and II, VZV, CMV and VDRL, West Nile Virus and Chagas screen. Donor must have normal negative test results for HIV, HTLV I and II, and West Nile Virus. Donor exposure to other viral pathogens will be discussed on a case-by-case basis by the investigators.
- Donor must be able to undergo leukopheresis for total volume of 10-15 liters.
- There is no age restriction for the donor.
Exclusion
- Patients with CR/VGPR disease
- Existing severe major organ dysfunction, i.e., renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity \> or = to grade 3 except for hearing loss, alopecia, anorexia, nausea, hyperbilirubinemia and hypomagnesemia from TPN, which may be grade 3
- ANC should be \>500/uL; platelet count \>25K/uL.
- History of allergy to mouse proteins
- Active life-threatening infection
- HAMA titer \>1000 Elisa units/ml
- Inability to comply with protocol requirements
- Donor Exclusion Criteria
- Cardiac risk factors precluding ability to undergo leukopheresis
- Concurrent malignancy or autoimmune disease
- Donor is pregnant.
Key Trial Info
Start Date :
April 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2019
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00877110
Start Date
April 2 2009
End Date
January 7 2019
Last Update
January 10 2019
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065