Status:
COMPLETED
Study of Donor Derived, Multi-virus-specific, Cytotoxic T-Lymphocytes for Relapsed/Refractory Neuroblastoma
Lead Sponsor:
Children's Mercy Hospital Kansas City
Collaborating Sponsors:
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Neuroblastoma
Eligibility:
All Genders
18-17 years
Phase:
PHASE1
Brief Summary
This is a single-center, investigator-initiated, single-arm, pilot study of post-allogeneic transplant, adoptive immunotherapy for the treatment of patients with relapsed/refractory neuroblastoma expr...
Detailed Description
Neuroblastoma (NB) is the most common extracranial tumor of childhood and prognosis for patients with relapsed or refractory disease is \< 10% and there is no standard therapy for these patients. Rese...
Eligibility Criteria
Inclusion
- Allogeneic transduced tV-CTLs with \>15% expression of 14g2a.zeta chimeric antigen receptor
- Patient or responsible person must be able to understand and sign a permission/assent or consent form for infusion
- Age 18 months through 17 years at time of relapse/progression
- Life expectancy \>8weeks
- Karnofsky score 60% or greater if 10 yrs old or older. Lansky score 60% or greater if under 10 yrs old
- Patient must be HIV negative
- ANC \>500
- Pulse ox\>90% on room air
- AST/ALT/direct bili \<5x upper limit of normal
- Recovered from toxic effects of all prior chemotherapy
- Absence of human/anti-mouse antibody (HAMA) (patients who have received prior therapy with murine antibodies)
- \>50% donor engraftment
Exclusion
- Patient pregnant or lactating or refuses birth control methods
- HIV positive
- Uncontrolled intercurrent infection
- Renal failure (creatinine clearance \<40ml/min/1.73m2)
- Active hepatitis or cirrhosis with bilirubin, AST, ALT \>5xnormal
- Rapidly progressive disease
- Currently receiving any investigational drugs
- Tumor potentially causing airway obstruction
- Cardiomegaly or bilateral pulmonary infiltrates on CXR
- Receiving \>0.25mg/kg/day methylprednisolone or equivalent systemic steroid. Topical steroid therapy is acceptable
- Receiving more than one lymphocyte inhibiting agent (ex. Tacrolimus/CSA and MMF or other similar agent
- Patients relapsing or progressing before the age of 18 months from Stage I/II disease, and/or those who, in the opinion of their oncologist, may benefit from further conventional therapy
- Donor lymphocyte infusion in last 28 days
- Evidence of GvHD greater than or equal to grade 2
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01460901
Start Date
October 1 2012
End Date
January 1 2015
Last Update
July 23 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108