Clinical trial · Interventional
Cellular Adoptive Immunotherapy Using Genetically Modified T-Lymphocytes in Treating Patients With Recurrent or Refractory High-Grade Malignant Glioma
Pilot Feasibility and Safety Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Genetically-Modified Autologous CD8+ T Cell Clones
NCT00730613CI-TRIAL-00029836completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (therapeutic autologous lymphocytes)
- description
- Patients receive an infusion of autologous antigen-specific CD8+ cytotoxic T-lymphocyte clones over 5-10 minutes on days 1, 3, and 5 of weeks 1 and 2. Treatment repeats every 3 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: therapeutic autologous lymphocytes
- Genetic: gene expression analysis
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Feasibility
- timeFrame
- 1 year after the end of treatment on study
- measure
- Safety
- timeFrame
- 1 year after the end of treatment on study
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.