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COMPLETED

NCT00730613

PHASE1

Cellular Adoptive Immunotherapy Using Genetically Modified T-Lymphocytes in Treating Patients With Recurrent or Refractory High-Grade Malignant Glioma

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: Pilot Feasibility and Safety Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Genetically-Modified Autologous CD8+ T Cell Clones

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2002-03-25

Completion Date

2011-08-01

Last Updated

2026-10-01

Healthy Volunteers

Conditions

Brain and Central Nervous System Tumors

Interventions

BIOLOGICAL

therapeutic autologous lymphocytes

Cycles of escalating cell dose infusions up to the target cell dose of 10(8)

GENETIC

gene expression analysis

At the time of excess pathology samples documenting response/relapse

OTHER

laboratory biomarker analysis

CSF generated at the time of each T-cell dose

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