Glioblastoma MultiformePhase 1NCT00990496
A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
A Phase 1 study testing Fludarabine, Cyclophosphamide and CMV Specific Cytotoxic T Lymphocytes (CTL) in people with Glioblastoma Multiforme, run by Milton S. Hershey Medical Center.
Trial summary
The primary purpose of this study is to determine the safety and efficacy of the infusion of partially matched, allogeneic, CMV specific cytotoxic T cells (CTL) for patients with GBM that have failed primary therapy. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Fludarabine, Cyclophosphamide and CMV Specific Cytotoxic T Lymphocytes (CTL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to 28 Oct 2010
- 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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- FOR SCREENING
- Patients must have a histopathologic diagnosis of GBM.
- Patients from 5 to 65 years of age with GBM.
- FOR TREATMENT
- GBM has progressed following primary therapy.
- Tumor is CMV pp65 or IE1 positive by immunohistochemistry (IHC).
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- Subjects must have pulse oximetry > or = 94 % on no supplemental oxygen.
- Creatinine clearance must be > 50 cc/min as estimated by patient's serum creatinine, weight, and age.
- Bilirubin must be < 2.0 mg/dl and SGOT/SGPT < 2.5 X normal.
- ECOG performance status must be < or = 2, and for patients <16 years of age, Lansky performance status must be > or = 70%.
Who cannot join
- Pregnant females
- Subjects who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month following the T cell infusion
About this study
Official title: A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)
The primary purpose of this study is to determine the safety and efficacy of the infusion of partially matched, allogeneic, CMV specific cytotoxic T cells (CTL) for patients with GBM that have failed primary therapy.
Read the detailed description
Tumor specimens of consenting patients will be tested by immunohistochemistry (IHC) for the presence of IE-1 and/or pp65. Subjects whose tumors test positive for either or both CMV antigens will be consented for the treatment phase which will include a regimen of fludarabine and cyclophosphamide daily for two days, cyclophosphamide only for a third day, followed by one day of rest prior to the day of CTL infusion.
This trial intended to be a Phase 1/2 trial, but it never progressed to Phase 2 before termination.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Fludarabine, Cyclophosphamide, CMV Specific Cytotoxic T Lymphocytes (CTL)
- Keywords
- Glioblastoma multiforme, GBM, Cytomegalovirus, CMV, Cytotoxic T lymphocyte, CTL
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
30 mg/m2
CyclophosphamideDrug
600 mg/m2
CMV Specific Cytotoxic T Lymphocytes (CTL)Biological
CTL Infusion (3 - 5 x 10E6 cells/kg)
| Study group | Role | What they receive |
|---|---|---|
| GBM Treatment | Experimental | Not described Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: CMV Specific Cytotoxic T Lymphocytes (CTL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.
Measured: 2 years
Secondary outcomes (3)
To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.
Measured: 2 years
To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.
Measured: 2 years
To determine safety of allogeneic CTL infusions in this patient population.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startSep 2009
- Primary completion28 Oct 2010
- Study completion28 Oct 2010
Why it stopped: Accrual goals not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Lucas G. Lucas, MD, Study chair, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990496
- Sponsor's protocol ID
- 31717
- Other IDs
- PSHCI #09-045
- Status last verified
- Apr 2018
- First submitted
- 5 Oct 2009
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)
- ClinicalTrials.gov ID
- NCT00990496
- Acronym / sponsor ID
- 31717
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma multiforme, GBM, Cytomegalovirus, CMV, Cytotoxic T lymphocyte, CTL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual goals not met
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- 28 Oct 2010 (actual)
- Study completion
- 28 Oct 2010 (actual)
- First posted
- 6 Oct 2009 (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 primary purpose of this study is to determine the safety and efficacy of the infusion of partially matched, allogeneic, CMV specific cytotoxic T cells (CTL) for patients with GBM that have failed primary therapy.
Detailed description
Tumor specimens of consenting patients will be tested by immunohistochemistry (IHC) for the presence of IE-1 and/or pp65. Subjects whose tumors test positive for either or both CMV antigens will be consented for the treatment phase which will include a regimen of fludarabine and cyclophosphamide daily for two days, cyclophosphamide only for a third day, followed by one day of rest prior to the day of CTL infusion.
This trial intended to be a Phase 1/2 trial, but it never progressed to Phase 2 before termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GBM Treatment | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Biological: CMV Specific Cytotoxic T Lymphocytes (CTL) |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- FOR SCREENING
- Patients must have a histopathologic diagnosis of GBM.
- Patients from 5 to 65 years of age with GBM.
- FOR TREATMENT
- GBM has progressed following primary therapy.
Key exclusion criteria (2 listed)
- Pregnant females
- Subjects who are moribund or who because of cardiac, pulmonary, renal, hepatic or neurologic dysfunction are not expected to survive one month following the T cell infusion
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 |
|---|---|---|
| Fludarabine30 mg/m2 | Drug | GBM Treatment |
| Cyclophosphamide600 mg/m2 | Drug | GBM Treatment |
| CMV Specific Cytotoxic T Lymphocytes (CTL)CTL Infusion (3 - 5 x 10E6 cells/kg) | Biological | GBM Treatment |
Primary outcome
To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.
Time frame: 2 years
3 secondary outcomes
To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.
Time frame: 2 years
To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.
Time frame: 2 years
To determine safety of allogeneic CTL infusions in this patient population.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Accrual goals not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
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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.
Kenneth Lucas G. Lucas, MD study chair
Milton S. Hershey Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fludarabine, Cyclophosphamide and CMV Specific Cytotoxic T Lymphocytes (CTL) in people with Glioblastoma Multiforme, run by Milton S. Hershey Medical Center.
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 10 inclusion and 2 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: stopped early, as of the sponsor's last update on 2 May 2018. 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 was stopped early (reason given: Accrual goals not met). Results are not available in the source record.
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?
To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2018.