Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00877110 |
Recruitment Status
:
Active, not recruiting
First Posted
: April 7, 2009
Last Update Posted
: May 2, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuroblastoma Bone Marrow, Sympathetic Nervous System | Drug: cyclophosphamide, vincristine, topotecan ,allogeneic NK cells & 3F8 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 71 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Study of Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma |
Actual Study Start Date : | April 2, 2009 |
Estimated Primary Completion Date : | April 2018 |
Estimated Study Completion Date : | April 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: chemotherapy, allogeneic NK cells, 3F8
This is a phase I study to assess the safety and feasibility of combining HLA-mismatched (KIR ligand incompatible) NK cells with 3F8 in high-risk NB patients. Following chemotherapy, patients will be treated in sequential groups of 3 patients/dose of NK cells. Four dose levels of NK cells, starting at dose level I, will be evaluated in this treatment protocol. In the unlikely case toxicity is encountered at dose level I, patients will then be treated at the lower dose level 0. Patients can receive up to 3 cycles of treatment on protocol. For subsequent cycles, patients will be treated at either less than or at the same dose level of NK cells as their first cycle.
|
Drug: cyclophosphamide, vincristine, topotecan ,allogeneic NK cells & 3F8
Patients will receive combination chemotherapy with intravenous (IV) cyclophosphamide 70mg/kg/day (for patients with body weight<70kg) or 2100mg/m2/day (for patients with body weight ≥70kg) for two days, IV vincristine 0.067mg/kg or 2mg/m2/day (lower of the two doses to be chosen; maximum 2mg) for one day, and IV topotecan 2.4 mg/m2/day for 3 days during their first cycle. If receiving a second and/or third cycle, the only chemotherapy patients will receive is cyclophosphamide at 50 mg/kg/day for 2 days. On Day 0, patients will receive a single dose of allogeneic NK cells isolated from a HLA-haploidentical related donor. On day +3, the patient will start daily infusion of 3F8 for 5 days. The treatment schedule may require minor adjustment by ±1 day as clinically indicated (e.g. due to PDH closure for holidays or due to inclement weather).
|
- Assess the feasibility and safety of administering allogeneic haploidentical NK infusions with 3F8 in patients with high-risk NB [ Time Frame: 3 years ]
- Estimate the anti-NB effect of allogeneic NK infusions plus 3F8 [ Time Frame: 3 years ]
- Assess the impact of KIR/HLA immunogenetics on disease response to NK/3F8 [ Time Frame: 3 years ]
- Assess the relationship between CD16 polymorphism and ADCC in vitro [ Time Frame: 3 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877110
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Shakeel Modak, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00877110 History of Changes |
Other Study ID Numbers: |
09-011 MSKCC09011 FDR004128 ( Other Grant/Funding Number: FDR004128 ) |
First Posted: | April 7, 2009 Key Record Dates |
Last Update Posted: | May 2, 2017 |
Last Verified: | May 2017 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
BETA-D-GLUCAN CYCLOPHOSPHAMIDE (CYTOXAN) MAB 131 I - 3F8 TOPOTECAN |
VINCRISTINE Neuroblastoma 09-011 |
Additional relevant MeSH terms:
Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Cyclophosphamide Vincristine Topotecan Antibodies Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |