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AzTrials

Anaplastic AstrocytomaPhase 1NCT01082926

Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2

A Phase 1 study testing therapeutic allogeneic lymphocytes, aldesleukin and laboratory biomarker analysis in people with Anaplastic Astrocytoma and Anaplastic Ependymoma, run by City of Hope Medical Center at 1 site in United States.

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: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Donor T cells that are treated in the laboratory may be effective treatment for malignant glioma. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
therapeutic allogeneic lymphocytes, aldesleukin and laboratory biomarker analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
22 Mar 2011to 23 Sep 2013
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

Who may be able to join

  • Histological verification of grade III or IV MG at original diagnosis
  • Radiographic evidence of progression/recurrence of the measurable disease more than 12 weeks after the end of radiation therapy
  • Expression of IL13Ralpha2 by immunohistochemistry
  • Karnofsky performance status (KPS) >= 60
  • Disease recurrence/progression in the cerebral hemisphere, which is in at least one area of enhancement amenable to biopsy after protocol enrollment in the following locations:
  • Adjacent or near previous resection cavity
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  • Distant from primary location; this includes tumor spread to contralateral hemisphere, corpus callosum, thalamus, basal ganglion, or subependymal locations
  • Research participant has recovered from toxicity of prior therapies; an interval of at least 12 weeks must have elapsed since the completion of radiation therapy; at least 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen; and at least 4 weeks since the completion of a non-nitrosourea-containing cytotoxic chemotherapy regimen; if a patient's most recent treatment was with a targeted agent only, and s/he has recovered from any toxicity of this targeted agent, then a waiting period of only 2 weeks is needed from the last dose and the start of study treatment, with the exception of bevacizumab where a wash out period of at least 4 weeks is required before starting study treatment
  • History of prior treatment with Temodar if no evidence of intolerance; documentation of intolerance to Temodar is not required
  • Creatinine < 1.6
  • White blood cell (WBC) >= 2,000/dl (or absolute neutrophil count [ANC] > 1,000) Platelets >= 100,000/dl unsupported by transfusion or growth factor, international normalized ratio (INR) < 1.3
  • Bilirubin < 1.5
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) < 2 X upper limits of normal
  • Female research participants of childbearing potential must not be pregnant as evidenced by a serum beta-HCG pregnancy test obtained within 7 days of enrollment
  • Research participants having reproductive potential must agree to use effective contraception during participation on this protocol
  • In the opinion of the neurosurgeon, research participant requires on-going dexamethasone therapy

Who cannot join

  • Survival expectation less than 4 weeks
  • Pulmonary- Requirement for supplemental oxygen use that is not expected to resolve within 2 weeks, Cardiac- Uncontrolled cardiac arrhythmia, hypotension requiring pressor support, Renal- Dialysis dependent, Neurologic- refractory seizure disorder, clinically evident progressive encephalopathy
  • Tumors with the following characteristics:
  • Large tumor recurrence causing significant symptoms from brain shift or mass effect, and thus not requiring "decompressive" craniotomy
  • Tumors located primarily in the basal ganglion or thalamus
  • Tumors with significant involvement of midbrain, cerebellum, pons and medulla will be excluded due to neurological risks associated with edema exacerbation from therapy
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  • Research participants with any non-malignant intercurrent illness which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it unwise to enter the research participant on protocol shall be ineligible
  • Positive human immunodeficiency virus (HIV) serology based on testing within 4 weeks of enrollment
  • Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
  • Failure to understand the basic elements of the protocol and/or the risks/benefits of participating in this pilot study
  • History of ganciclovir and/or magnetic resonance imaging (MRI) contrast allergy or intolerance History of intolerance to IL-2

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope

    Duarte, California, 91010

Other trials in United States

About this study

RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Donor T cells that are treated in the laboratory may be effective treatment for malignant glioma. Aldesleukin may stimulate the white blood cells to kill tumor cells. Combining different types of biological therapies may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best way to give therapeutic donor lymphocytes together with aldesleukin in treating patients with stage III or stage IV malignant glioma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the safety of GRm13Z40-2 CTL CNS loco-regional cellular immunotherapy in research participants with recurrent or refractory/ progressive malignant glioma (WHO Grades 3 or 4).

II. To assess the safety of convection enhanced delivery (CED) of recombinant human Interleukin-2 (rhuIL-2) used in conjunction with GRm13Z40-2 CTL adoptive transfer.

SECONDARY OBJECTIVES:

  1. To investigate the ability of 9-(4-fluoro-3-hydroxy-methyl-butyl) guanine (18FHBG) positron emission tomography PET to image GRm13Z40-2 CTL's in research participants.

II. To study the impact of concurrent dexamethasone administration on the tempo and magnitude of T cell allograft rejection responses in treated research participants by tracking the frequency of anti-GRm13Z40-2 immune responses in serially acquired peripheral blood samples.

III. To evaluate ganciclovir administration for ablating transferred GRm13Z40-2 in vivo should significant graft-mediated toxicities be encountered.

OUTLINE: Patients receive GRm13Z40-2 therapeutic allogeneic lymphocytes intratumorally (IT) over 10 minutes on days 1 and 3 and aldesleukin IT over 3 hours on days 2-5 (days 1-5 in week 2). Treatment repeats every week for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed annually for at least 15 years.

Being tested
therapeutic allogeneic lymphocytes, aldesleukin, laboratory biomarker analysis, positron emission tomography
Keywords
adult anaplastic astrocytoma, adult anaplastic ependymoma, adult anaplastic meningioma, adult anaplastic oligodendroglioma, adult brain stem glioma, adult ependymoblastoma, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma, adult grade III meningioma, adult meningeal hemangiopericytoma, adult mixed glioma, adult pineal gland astrocytoma, recurrent adult brain tumor, Los Angeles
Medical subject headings
Astrocytoma, Ependymoma, Meningioma, Oligodendroglioma, Neuroectodermal Tumors, Primitive, Glioblastoma, Gliosarcoma, Glioma

What participants receive

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

  • therapeutic allogeneic lymphocytesBiological

    Also called ALLOLYMPH

    Given intratumorally

  • aldesleukinBiological

    Also called IL-2, interleukin II, Proleukin, recombinant human interleukin-2

    Given intratumorally

  • laboratory biomarker analysisOther

    Optional correlative studies

  • positron emission tomographyProcedure or surgery

    Also called FDG-PET, PET, PET scan, tomography, emission computed

    Optional correlative studies

Study groups in NCT01082926
Study groupRoleWhat they receive
Arm IExperimentalPatients receive intratumoral GRm13Z40-2 therapeutic allogeneic lymphocytes over 10 minutes on days 1 and 3 and intratumoral aldesleukin over 3 hours on days 2-5 (days 1-5 in week 2). Treatment repeats every week for 2 courses in the absence of disease progression or unacceptable toxicity.
Receives: Biological: therapeutic allogeneic lymphocytes; Biological: aldesleukin; Other: laboratory biomarker analysis; Procedure: positron emission tomography

What is being measured

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

  1. Safety of GRm13Z40-2 CTL CNS loco-regional cellular immunotherapy

    Measured: Daily for first 2 weeks, weekly for month 1, every other week for month 2 , monthly for 6 months

  2. Safety of convection enhanced delivery (CED) of recombinant human Interleukin-2 (rhuIL-2) used in conjunction with GRm13Z40-2 CTL adoptive transfer

    Measured: Weeks 1 and 2

  3. Toxicity as assessed by NCI CTCAE version 4.0

    Measured: During treatment and up to 21 days after the last GRm13Z40-2 or CED rhuIL-2 infusion

Secondary outcomes (3)

  1. Ability of 9-(4-fluoro-3-hydroxy-methyl-butyl) guanine (18FHBG) positron emission tomography PET to image GRm13Z40-2 CTLs

    Measured: Prior to immunotherapy and 3 weeks post immunotherapy

  2. Impact of concurrent dexamethasone on the tempo and magnitude of T cell allograft rejection responses by tracking the frequency of anti-GRm13Z40-2 immune responses in serially acquired peripheral blood samples

    Measured: Post infusion day 1, weeks 2-4 and week 8

  3. Evaluation of ganciclovir administration for ablating transferred GRm13Z40-2 in vivo should significant graft-mediated toxicities be encountered

    Measured: When/if grade 3 or 4 toxicity occurs

Timeline

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

  1. First posted9 Mar 2010 (estimated)
  2. Study start22 Mar 2011
  3. Primary completion23 Sep 2013
  4. Study completion23 Sep 2013

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01082926
Sponsor's protocol ID
07082
Other IDs
NCI-2010-00303
Status last verified
Oct 2026
First submitted
5 Mar 2010
Last updated
19 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 allogeneic lymphocytes, aldesleukin and laboratory biomarker analysis in people with Anaplastic Astrocytoma and Anaplastic Ependymoma, run by City of Hope Medical Center at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Safety of GRm13Z40-2 CTL CNS loco-regional cellular immunotherapy (time frame: Daily for first 2 weeks, weekly for month 1, every other week for month 2 , monthly for 6 months). The study lists 3 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 NCT01082926.

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 19 Oct 2026.

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