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Brain and Central Nervous System TumorsPhase 1NCT00730613

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

A Phase 1 study testing therapeutic autologous lymphocytes, gene expression analysis and laboratory biomarker analysis in people with Brain and Central Nervous System Tumors, run by City of Hope Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
therapeutic autologous lymphocytes, gene expression analysis and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
No sites listed yet
Study dates
25 Mar 2002to 1 Aug 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

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

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.

Read the detailed description

OBJECTIVES:

Primary

  • To assess the feasibility and safety of cellular immunotherapy utilizing ex vivo expanded autologous CD8-positive T-cell clones genetically modified to express the IL-13 zetakine chimeric immunoreceptor and the Hy/TK selection/suicide fusion protein in patients with recurrent or refractory, high-grade malignant glioma.

Secondary

  • To evaluate the antitumor activity of adoptively transferred clones in these patients.
  • To screen for the development of anti-IL13 zetakine and anti-HyTK immune responses in these patients.
  • To evaluate the efficacy of ganciclovir administration for ablating transferred clones in vivo should toxicity be encountered.

OUTLINE:

  • Leukapheresis and therapy preparation: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells. T-cells isolated from the peripheral blood are then genetically modified, hygromycin-resistant cloned, expanded ex vivo, and cryopreserved until the first clinical or radiographic evidence of recurrence or progression. Patients with documented disease recurrence or progression undergo re-biopsy or re-resection of the tumor and placement of a reservoir-access device (Rickham shunt) into the tumor resection cavity prior to autologous T-cell clone infusion therapy.
  • Autologous T-cell clone infusion: 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. Patients achieving tumor regression with residual disease by MRI after 4 courses of study therapy may receive up to 2 additional courses in the absence of disease progression, unacceptable toxicity, or a complete response.

Patients undergo blood, cerebrospinal fluid, and tissue sample collection periodically for correlative studies. Samples are assessed for IL13Rα2 expression levels, susceptibility to redirected T-cell effector mechanisms, and other tumor and T-cell activation markers.

After completion of study treatment, patients will be followed monthly for 3 months, then every 3 months for two years, and then annually for at least 15 years.

Being tested
therapeutic autologous lymphocytes, gene expression analysis, laboratory biomarker analysis
Keywords
adult anaplastic astrocytoma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult subependymal giant cell astrocytoma, adult anaplastic ependymoma, adult ependymoma, adult myxopapillary ependymoma, adult subependymoma, adult anaplastic oligodendroglioma, adult oligodendroglioma, adult brain stem glioma, adult giant cell glioblastoma, adult glioblastoma, recurrent adult brain tumor, adult gliosarcoma, adult mixed glioma, adult pineal gland astrocytoma
Medical subject headings
Central Nervous System Neoplasms, Astrocytoma, Ependymoma, Glioma, Subependymal, Oligodendroglioma, Glioblastoma, Brain Neoplasms, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • therapeutic autologous lymphocytesBiological

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

  • gene expression analysisGenetic

    At the time of excess pathology samples documenting response/relapse

  • laboratory biomarker analysisOther

    CSF generated at the time of each T-cell dose

Study groups in NCT00730613
Study groupRoleWhat they receive
Treatment (therapeutic autologous lymphocytes)ExperimentalPatients 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.
Receives: Biological: therapeutic autologous lymphocytes; Genetic: gene expression analysis; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

    Measured: 1 year after the end of treatment on study

  2. Safety

    Measured: 1 year after the end of treatment on study

Secondary outcomes (3)

  1. Anti-tumor activity of adoptively transferred clones

    Measured: 1 year after the end of treatment on study

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

    Measured: 1 year after the end of treatment on study

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

    Measured: 1 year after the end of treatment on study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2008 (estimated)
  2. Study start25 Mar 2002
  3. Primary completion1 Aug 2011
  4. Study completion1 Aug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00730613
Sponsor's protocol ID
01020
Other IDs
P30CA033572, CHNMC-01020, CDR0000590506
Status last verified
Sep 2026
First submitted
7 Aug 2008
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing therapeutic autologous lymphocytes, gene expression analysis and laboratory biomarker analysis in people with Brain and Central Nervous System Tumors, run by City of Hope Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: 1 year after the end of treatment on study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00730613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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Clinical Trial NCT00730613 | AzTrials