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View Clinical Trial (Medical Research Study)
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Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma - NCT00877110-10065 (Clinical Trial 282700)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy282700.aspx
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10065 |
| Conditions: |
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Neuroblastoma - Bone Marrow, Sympathetic Nervous System |
| Purpose: |
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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 from a family member
who shares half of the HLA proteins which are immune proteins important in transplant. NK
cells are a type of white blood cell. They can recognize and kill abnormal cells in the body
and can work together with antibodies to kill target cells. The antibody 3F8 specifically
recognizes a protein present on the target cancer cell.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- 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 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 Criteria:
- 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. |
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| Study is available at: |
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Memorial Sloan-Kettering Cancer Center
New York, NY 10065
United States
Primary Contact:
Shakeel Modak, MD
Phone: 212-639-7623
Secondary Contact:
Shakeel Modak, MD
Phone: 212-639-7623 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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