Brain and Central Nervous System Tumors Clinical Trial
Official title:
Pilot Feasibility and Safety Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Genetically-Modified Autologous CD8+ T Cell Clones
Verified date | October 2017 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Cellular adoptive immunotherapy may stimulate the immune system in different ways
and stop cancer cells from growing.
PURPOSE: This clinical trial is studying the side effects of cellular adoptive immunotherapy
using genetically modified T-lymphocytes and to see how well it works in treating patients
with recurrent or refractory high-grade malignant glioma.
Status | Completed |
Enrollment | 3 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed malignant glioma at original diagnosis - Grade III or IV disease - Refractory or recurrent disease - Unifocal site of original disease in cerebral cortex - No clinical evidence of progressive encephalopathy - Has not undergone recent re-resection of recurrent or progressive disease - No communication between the tumor resection cavity and the ventricles and deep cerebrospinal fluid pathways as documented by post-operative MRI scan PATIENT CHARACTERISTICS: - Karnofsky performance status 70-100% - Life expectancy > 3 months - WBC = 2,000/dL - ANC > 1,000/dL - Platelet count = 100,000/dL (unsupported by transfusion or growth factor) - Creatinine < 1.6 mg/dL - Bilirubin < 1.5 - SGOT and SGPT < 2 times upper limit of normal - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - Able to understand protocol basic elements and/or risks/benefits of participating in this pilot study - No requirement for supplemental oxygen to keep saturation > 95% that is not expected to resolve within 2 weeks - No uncontrolled cardiac arrhythmia - No hypotension requiring pressor support - No renal dialysis dependency - No refractory seizure disorder - No concurrent non-malignant illness that is poorly controlled with treatment or is of such severity the investigators deem it unwise to enter the patient on protocol - No severe infection for which patient is being treated - No history of ganciclovir and/or Prohance contrast allergy or intolerance - No HIV positivity within the past 3 months PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Must have recovered from major surgery - At least 4 weeks since primary therapy and no steroid dependence - At least 2 weeks since prior adjuvant cytotoxic chemotherapy and recovered - No concurrent systemic corticosteroids, except for use in managing T-cell therapy toxicity - No concurrent immunotherapy (i.e., interferons, vaccines, or other cellular products) - No concurrent pentoxifylline - No other concurrent investigative agents - No concurrent ganciclovir or ganciclovir derivative - No concurrent acyclovir for non-life threatening herpes virus infection |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility | 1 year after the end of treatment on study | ||
Primary | Safety | 1 year after the end of treatment on study | ||
Secondary | Anti-tumor activity of adoptively transferred clones | 1 year after the end of treatment on study | ||
Secondary | Anti-IL 13 zetakine and anti-HyTK immune response in patients | 1 year after the end of treatment on study | ||
Secondary | Efficacy of ganciclovir for clone ablation (in the event of toxicity) | 1 year after the end of treatment on study |
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