GliomasPhase 1alloCTLNCT01144247
Cellular Immunotherapy Study for Brain Cancer
A Phase 1 study testing alloreactive CTL in people with Gliomas and Anaplastic Astrocytoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this research study to determine if treating recurrent malignant gliomas with another person's (donor) immune system cells known as aCTL cells, will be safe. This study will also try to determine if persons who receive aCTL's are more or less likely to survive their brain tumor than persons who had… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gliomas, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma
- What is being tested?
- alloreactive CTL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To participate in this clinical trial, patients must meet the following eligibility criteria:
- Subjects must have a histologically proven diagnosis of malignant glioma or meningioma and been treated with prior standard radiation and chemotherapy. There must be evidence of unequivocal progression by MRI.
- Tumor must be amenable to resection, and surgical resection must be clinically indicated.
- Age at least 18 years.
- Karnofsky performance scale score >60.
- Adequate hematologic function: a) systemic white blood cell count greater than 2 x 103/mm3, b) platelet count greater than 100,000/mm3, c) hematocrit greater than 25%.
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- Adequate renal function, with creatinine less than two times the upper limit.
- Adequate hepatic function, with SGOT, alkaline phosphatase, and total bilirubin < 2x upper limit of normal.
- Patients must have an expected survival of at least three months.
- Patients must not have a history of HTLV, HIV, syphilis by RPR, hepatitis B and C.
- Patients must sign an informed consent.
Who cannot join
- Patients will be excluded from the trial if the patients:
- have multifocal tumors, bihemispheric tumors, infratentorial tumors, or non-surgically accessible tumors.
- have prior tumor resections where the ventricles were extensively breached.
- are pregnant or breast-feeding women.
- are females of child-bearing potential unable or unwilling to practice adequate birth control methods.
- have contraindications for brain MRI scanning (e.g., intra-ocular metal fragments, cerebral aneurysm clips, pacemaker).
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- have concurrent malignancy, excluding curatively treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- have concurrent systemic infection.
- have any clinically significant, uncontrolled medical illness, as determined by the investigators.
- are unwilling or unable to comply with procedures required in this protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: A Phase I Clinical Trial Evaluating Cellular Immunotherapy With Intratumoral Alloreactive Cytotoxic T Lymphocytes and Interleukin-2 for the Treatment of Recurrent Malignant Gliomas or Meningiomas
The purpose of this research study to determine if treating recurrent malignant gliomas with another person's (donor) immune system cells known as aCTL cells, will be safe. This study will also try to determine if persons who receive aCTL's are more or less likely to survive their brain tumor than persons who had similar tumors in the past. Approximately 15 patients will be enrolled at UCLA.
- Conditions
- Gliomas, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Mixed Glioma, Glioblastoma Multiforme, Malignant Meningioma
- Being tested
- alloreactive CTL
- Keywords
- Recurrent Grade III or Grade IV Gliomas, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, glioblastoma multiforme, biotherapy, malignant meningioma
- Medical subject headings
- Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma, Meningioma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alloreactive CTLDrug
cellular immunotherapy with alloCTL
| Study group | Role | What they receive |
|---|---|---|
| alloreactive CTL arm | Experimental | Not described Receives: Drug: alloreactive CTL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events as a measure of safety and tolerability
Measured: 5 years
Secondary outcomes (1)
Maximum tolerated dose
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GliomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144247
- Sponsor's protocol ID
- UCLA 07-09-008
- Other IDs
- R01CA125244
- Acronym
- alloCTL
- Status last verified
- May 2016
- First submitted
- 11 Jun 2010
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hickey MJ, Malone CC, Erickson KL, Jadus MR, Prins RM, Liau LM, Kruse CA. Cellular and vaccine therapeutic approaches for gliomas. J Transl Med. 2010 Oct 14;8:100. doi: 10.1186/1479-5876-8-100.
PubMed 20946667Hickey MJ, Malone CC, Erickson KE, Gomez GG, Young EL, Liau LM, Prins RM, Kruse CA. Implementing preclinical study findings to protocol design: translational studies with alloreactive CTL for gliomas. Am J Transl Res. 2012;4(1):114-26. Epub 2012 Jan 10.
PubMed 22347526Kruse CA, Cepeda L, Owens B, Johnson SD, Stears J, Lillehei KO. Treatment of recurrent glioma with intracavitary alloreactive cytotoxic T lymphocytes and interleukin-2. Cancer Immunol Immunother. 1997 Oct;45(2):77-87. doi: 10.1007/s002620050405.
PubMed 9390198Kruse, C.A., Rubinstein, D. (2001) Cytotoxic T Lymphocytes Reactive to Patient Major Histocompatibility Proteins for Therapy of Recurrent Primary Brain Tumors, in Brain Tumor Immunotherapy, eds. L.M. Liau, D.P. Becker, T.F. Cloughsey, and D. Bigner, Humana Press, pp. 149-170
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Evaluating Cellular Immunotherapy With Intratumoral Alloreactive Cytotoxic T Lymphocytes and Interleukin-2 for the Treatment of Recurrent Malignant Gliomas or Meningiomas
- ClinicalTrials.gov ID
- NCT01144247
- Acronym / sponsor ID
- alloCTL / UCLA 07-09-008
- Conditions
- Gliomas, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Mixed Glioma, Glioblastoma Multiforme, Malignant Meningioma
- Keywords
- Recurrent Grade III or Grade IV Gliomas, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, glioblastoma multiforme, biotherapy, malignant meningioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Jul 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study to determine if treating recurrent malignant gliomas with another person's (donor) immune system cells known as aCTL cells, will be safe. This study will also try to determine if persons who receive aCTL's are more or less likely to survive their brain tumor than persons who had similar tumors in the past. Approximately 15 patients will be enrolled at UCLA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| alloreactive CTL arm | Experimental | Drug: alloreactive CTL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- To participate in this clinical trial, patients must meet the following eligibility criteria:
- Subjects must have a histologically proven diagnosis of malignant glioma or meningioma and been treated with prior standard radiation and chemotherapy. There must be evidence of unequivocal progression by MRI.
- Tumor must be amenable to resection, and surgical resection must be clinically indicated.
- Age at least 18 years.
- Karnofsky performance scale score >60.
Key exclusion criteria (10 listed)
- have multifocal tumors, bihemispheric tumors, infratentorial tumors, or non-surgically accessible tumors.
- have prior tumor resections where the ventricles were extensively breached.
- are pregnant or breast-feeding women.
- are females of child-bearing potential unable or unwilling to practice adequate birth control methods.
- have contraindications for brain MRI scanning (e.g., intra-ocular metal fragments, cerebral aneurysm clips, pacemaker).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alloreactive CTLcellular immunotherapy with alloCTL | Drug | alloreactive CTL arm |
Primary outcome
Number of patients with adverse events as a measure of safety and tolerability
Time frame: 5 years
1 secondary outcome
Maximum tolerated dose
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Background: PubMed 20946667Hickey MJ, Malone CC, Erickson KL, Jadus MR, Prins RM, Liau LM, Kruse CA. Cellular and vaccine therapeutic approaches for gliomas. J Transl Med. 2010 Oct 14;8:100. doi: 10.1186/1479-5876-8-100.
- Background: PubMed 22347526Hickey MJ, Malone CC, Erickson KE, Gomez GG, Young EL, Liau LM, Prins RM, Kruse CA. Implementing preclinical study findings to protocol design: translational studies with alloreactive CTL for gliomas. Am J Transl Res. 2012;4(1):114-26. Epub 2012 Jan 10.
- Results publication: PubMed 9390198Kruse CA, Cepeda L, Owens B, Johnson SD, Stears J, Lillehei KO. Treatment of recurrent glioma with intracavitary alloreactive cytotoxic T lymphocytes and interleukin-2. Cancer Immunol Immunother. 1997 Oct;45(2):77-87. doi: 10.1007/s002620050405.
- Results publicationKruse, C.A., Rubinstein, D. (2001) Cytotoxic T Lymphocytes Reactive to Patient Major Histocompatibility Proteins for Therapy of Recurrent Primary Brain Tumors, in Brain Tumor Immunotherapy, eds. L.M. Liau, D.P. Becker, T.F. Cloughsey, and D. Bigner, Humana Press, pp. 149-170
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing alloreactive CTL in people with Gliomas and Anaplastic Astrocytoma, run by Jonsson Comprehensive Cancer 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 11 inclusion and 10 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 27 May 2016. 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?
Number of patients with adverse events as a measure of safety and tolerability (time frame: 5 years). 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 NCT01144247, which also lists 4 linked publications.
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 27 May 2016.