Study Stopped
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Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Expanded Haploidentical NK Cells and Hu14.18-IL2
7 other identifiers
interventional
N/A
1 country
1
Brief Summary
Subjects with relapsed or refractory neuroblastoma and osteosarcoma will receive ex-vivo expanded and activated natural killer (NK) cells from a haploidentical donor in conjunction with the immunocytokine, hu14.18-IL2.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2018
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedStudy Start
First participant enrolled
March 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2022
CompletedSeptember 13, 2022
September 1, 2022
4.5 years
June 13, 2017
September 12, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Safety: Incidence of treatment-emergent adverse events of treatment with AENK cells and hu14.18-IL2
Safety will be assessed by quantifying adverse events ≥ grade 3, using CTCAE (v.5), with certain pre-defined exceptions based on known, transient, reversible, clinically manageable toxicities of the chemotherapy and hu14.18-IL2.
up to 28 days after final dose of EA-NK cells or hu14.18-IL2, whichever occurs last
Safety: Incidence of any grade acute or chronic GVHD
Safety will be assessed by monitoring for any grade acute or chronic GVHD.
up to 21 days after final dose of EA-NK cells or hu14.18-IL2, whichever occurs last
Secondary Outcomes (9)
Efficacy: Progression free survival
up to12 months after final dose of EA-NK cells or hu14.18-IL2, whichever occurs last
Efficacy: Overall survival
up to12 months after final dose of EA-NK cells or hu14.18-IL2, whichever occurs last
Efficacy: Objective tumor response (SD + CR + PR)
up to12 months after final dose of EA-NK cells or hu14.18-IL2, whichever occurs last
Longevity of EA-NK cells in vivo
28 days
Immunocytokine (hu14.18-IL2) serum levels given as daily infusions for 7 consecutive days
up to 28 days after last hu14.18-IL2 infusion
- +4 more secondary outcomes
Study Arms (1)
Single arm
EXPERIMENTALAll subjects will receive Ex vivo Expanded and Activated Haploidentical Donor NK Cells + hu14.18-IL2
Interventions
Haploidentical donor NK cells that are expanded and activated under current GMP conditions using K562-mbIL15-41BBL.
The immunocytokine, hu14.18-IL2, is a fusion protein comprised of one molecule of the anti-GD2 humanized monoclonal antibody, hu14.18, fused to two molecules of the cytokine, interleukin-2.
Eligibility Criteria
You may qualify if:
- Relapsed or refractory neuroblastoma
- Relapsed or refractory Osteosarcoma
- Karnofsky/Lansky performance score \> 50
- Life expectancy ≥ 4 months
- Creatinine clearance or radioisotope GFR ≥ 60 ml/min/1.73m2 OR serum creatinine within normal limits based on age and gender
- ANC ≥ 750/µL
- Platelet count ≥ 50,000/µL
- Hemoglobin ≥ 8 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal for age
- ALT (SCPT) ≤ 5 x upper limit of normal for age
- Shortening fraction of ≥ 27% by echocardiogram OR Ejection fraction of ≥55% by MUGA
- No evidence of dyspnea at rest
- Pulse oximetry \> 94% on room air
- If PFTs performed, FEV1/FVC must be \> 60%
- All Osteosarcoma patients must have PFTs performed
- +13 more criteria
You may not qualify if:
- Prior history of ventilator support related to lung injury, except for immediately following thoracotomy
- Symptomatic pleural effusions or ascites
- \<6 weeks from thoracotomy and \<2 weeks from other major surgery
- History of anaphylaxis while receiving prior anti-GD2 therapy
- Pregnant
- HIV infection
- Heart failure or uncontrolled cardiac rhythm disturbance
- Active infection
- Prior organ allograft
- Prior allogeneic bone marrow or peripheral blood stem cell transplant
- Significant serious intercurrent illnesses expected to interfere with the antitumor effect of treatment or to significantly increase the severity of toxicities experienced from treatment
- Any mental or physical condition, in the opinion of the PI (or PI designee), which could interfere with the ability of the subject (or the only parent or legal guardian available to care for the subject) to understand or adhere to the requirements of the study.
- Enrollment in any other treatment study from screening up to 28 days after the last treatment on this study (unless PI judges such enrollment would not interfere with endpoints of this study)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- National Cancer Institute (NCI)collaborator
- Solving Kids' Cancercollaborator
- Midwest Athletes Against Childhood Cancer, Inc. (MACC Fund)collaborator
- Wade's Armycollaborator
- The Catherine Elizabeth Blair Memorial Foundation / GWCFcollaborator
Study Sites (1)
University of Wisconsin Carbone Cancer Center; UW Hospital and Clinics
Madison, Wisconsin, 53792, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ken DeSantes, MD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2017
First Posted
July 6, 2017
Study Start
March 12, 2018
Primary Completion
September 7, 2022
Study Completion
September 7, 2022
Last Updated
September 13, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share