NCT00730613

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_1

Status
completed

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

Study Start

First participant enrolled

February 1, 2002

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

9.5 years

First QC Date

August 7, 2008

Last Update Submit

October 6, 2017

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytomaadult diffuse astrocytomaadult pilocytic astrocytomaadult subependymal giant cell astrocytomaadult anaplastic ependymomaadult ependymomaadult myxopapillary ependymomaadult subependymomaadult anaplastic oligodendrogliomaadult oligodendrogliomaadult brain stem gliomaadult giant cell glioblastomaadult glioblastomarecurrent adult brain tumoradult gliosarcomaadult mixed gliomaadult pineal gland astrocytoma

Outcome Measures

Primary Outcomes (2)

  • Feasibility

    1 year after the end of treatment on study

  • Safety

    1 year after the end of treatment on study

Secondary Outcomes (3)

  • Anti-tumor activity of adoptively transferred clones

    1 year after the end of treatment on study

  • Anti-IL 13 zetakine and anti-HyTK immune response in patients

    1 year after the end of treatment on study

  • Efficacy of ganciclovir for clone ablation (in the event of toxicity)

    1 year after the end of treatment on study

Study Arms (1)

Treatment (therapeutic autologous lymphocytes)

EXPERIMENTAL

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.

Biological: therapeutic autologous lymphocytesGenetic: gene expression analysisOther: laboratory biomarker analysis

Interventions

therapeutic autologous lymphocytesBIOLOGICAL

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

Treatment (therapeutic autologous lymphocytes)
gene expression analysisGENETIC

At the time of excess pathology samples documenting response/relapse

Treatment (therapeutic autologous lymphocytes)
laboratory biomarker analysisOTHER

CSF generated at the time of each T-cell dose

Treatment (therapeutic autologous lymphocytes)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Central Nervous System NeoplasmsAstrocytomaEpendymomaGlioma, SubependymalOligodendrogliomaGlioblastomaBrain NeoplasmsGliosarcomaGlioma

Interventions

Gene Expression Profiling

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative Techniques

Study Officials

  • Stephen Forman, MD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

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

August 7, 2008

First Posted

August 8, 2008

Study Start

February 1, 2002

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 9, 2017

Record last verified: 2017-10