GlioblastomaPhase 1ERaDICATeNCT00693095
Evaluation of Recovery From Drug-Induced Lymphopenia Using Cytomegalovirus-specific T-cell Adoptive Transfer
A Phase 1 study testing CMV-ALT + CMV-DCs and CMV-ALT + Saline in people with Glioblastoma, run by John Sampson at 1 site in United States.
Trial summary
The purpose of this research study is to learn if your own immune cells can be activated and multiplied in order to help your body fight off the tumor cells in your brain. The safety of this procedure will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- CMV-ALT + CMV-DCs and CMV-ALT + Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Apr 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
- Age >18 years of age.
- GBM (WHO Grade IV) with definitive resection <4 weeks prior to leukapheresis with residual radiographic contrast enhancement on post-resection CT or MRI of <1 cm in maximal diameter in any axial plane.
- Karnofsky Performance Status (KPS ) of > 80% and a Curran Group status of I-IV.
Who cannot join
- Radiographic or cytologic evidence of leptomeningeal or multicentric disease at any time prior to vaccination.
- Prior conventional anti-tumor therapy other than steroids, RT, or TMZ.
- Pregnant or need to breast feed during the study period (Negative b-HCG test required).
- Requirement for continuous corticosteroids above physiologic levels at time of first vaccination.
- Active infection requiring treatment or an unexplained febrile (> 101.5o F) illness.
- Known immunosuppressive disease or human immunodeficiency virus infection.
Show all 9Show fewer
- Patients with unstable or severe intercurrent medical conditions such as severe heart or lung disease.
- Allergic or unable to tolerate TMZ for reasons other than lymphopenia.
- Patients with previous inguinal lymph node dissection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of this research study is to learn if your own immune cells can be activated and multiplied in order to help your body fight off the tumor cells in your brain. The safety of this procedure will also be studied. This procedure, called CMV-autologous lymphocyte transfer or CMV-ALT is investigational which means that it is not approved by the US Food and Drug Administration (FDA) and is still being tested in research studies. Autologous lymphocyte transfer or ALT means that you will receive your own immune cells back (and not from another donor) as a treatment after they have been activated and grown to large numbers in a clinical lab.
It is believed that the body's immune (protection) system can attack tumor cells and kill them. Immune cells called T-lymphocytes (T-cells) can recognize special proteins on the surface of tumors as a signal to attack and fight the cancer. In most patients with advanced cancer, the immune system does not adequately destroy the tumor because the white blood cells or T-cells are not stimulated enough.
Read more
Before your T-cells can become active against tumor cells, they require strong stimulation. There are special "stimulator" cells in the body called Dendritic Cells (DCs) that can take up proteins released from cancer cells and present pieces of these proteins to T lymphocytes to create this strong stimulation. Dendritic cells taken from your blood will be "pulsed" or loaded with genetic material called RNA (ribonucleic acid), which stimulates the DC to change the RNA into a protein called pp65. This protein is produced by a common virus called Cytomegalovirus (CMV) that 70-80% of us have been exposed to in our lifetime. Recently, we have found that this virus is present in many malignant brain tumors. Brain tumors are very aggressive and, for reasons we do not yet understand, are difficult for the body to attack. The CMV virus is a target in the tumor that, if attacked by your immune systems cells, may prevent your tumor from growing. We have found that we can grow immune cells to very large numbers from the blood of people who have evidence of prior exposure to this virus. You will therefore be tested to determine if you have pre-existing antibodies to this virus in order to participate in this study.
We will use your DCs to activate and grow immune cells from your blood to large numbers in a clinical laboratory. These CMV-specific immune cells, called CMV-ALT, will be returned to your body when they have become activated. It is hoped that these cells will seek out and kill tumor cells that express the CMV viral protein and not attack normal cells. The transfer of immune cells that stimulates your immune system is called adoptive immunotherapy. We will evaluate two doses of immune cells in this study (Dose 1 and Dose 2). Depending on when you are enrolled in this study you will receive either Dose 1 or 2. The first six patients enrolled on this study will receive Dose 1 (the lower dose) and the next six patients will receive Dose 2 (the higher dose). We do not know at this time if either dose is more effective or safer to administer which is why we are testing both doses. Dose 2 will be a larger number of immune cells if the treatment is found to be safe in the first six patients treated during this study.
In this study we will also see, in some randomly selected patients, if giving an injection of the DC pulsed with pp65 RNA into the skin improves the function of the CMV-ALT treatment or not. You will receive three injections under the skin of either some of the same DC that were used to stimulate your immune cells in the clinical laboratory or three injections of saline (salt solution) under the skin starting with the infusion of the CMV-ALT. It is unknown if a DC injection will be beneficial to the immune cells or not so the responses will be compared in patients who receive DC versus saline injection with their CMV-ALT. After these three injections, blood will be collected to compare the responses between patients that received saline to those that received DC injections.
Read the detailed description
Six CMV seropositive patients with newly-diagnosed GBM will be randomized to receive CMV-ALT (3 x 107/Kg) with or without vaccine with CMV-DCs (2 x 107). All patients will undergo a leukapheresis after resection for harvest of PBLs for CMV-ALT and CMV-DC generation. Patients will then receive RT and concurrent TMZ at a standard targeted dose of 75 mg/m2/d. Patients with histologically or clinically-proven progressive disease during radiation, dependent on steroid supplements above physiologic levels at time of vaccination, and are unable to tolerate TMZ will be replaced. If sufficient CMV-specific T-cells can't be expanded or ALT doesn't meet release criteria, the patient will be replaced and their cells may be used to offer them another DC vaccination study, such as ATTAC Pro00003877. Remaining patients will then receive the initial cycle of TMZ at a standard targeted dose of 200mg/m2/d for 5 days 3 + 1 weeks after completing RT and will be randomized to receive CMV-DCs or saline simultaneous with CMV-ALT as vaccine #1. While the standard targeted dose of 200mg/m2/d for 5 days TMZ treatment is recommended, TMZ regimen may be adjusted at the discretion of the treating neuro-oncologist. Patients with MRI changes consistent with pseudoprogression who continue on TMZ will receive CMV-ALT with vaccinations as scheduled. Peripheral blood will be drawn at 0 hours, 24 hours, 48 hours, 72 hours, and 1 week post vaccine #1 for T-cell kinetics. DCs or saline will be given intradermally and divided equally to both inguinal regions. Vaccines #2 and #3 will occur at 2 week intervals. All patients will then undergo leukapheresis again for immunologic monitoring with specific assessment of baseline antigen-specific cellular and humoral immune responses.
If the initial dose of CMV-ALT is safe and the combination of CMV-DCs is safe and does not produce an inferior CMV pp65-specific immune response, a 3rd cohort of patients will be enrolled and receive a higher dose of CMV-ALT (3 x 108/Kg) along with vaccine with CMV-DCs (2 x 107). If the combination is unsafe or inferior only the CMV-ALT will be given. If CMV-ALT (3 x 108/Kg) is safe a 4th cohort of 3 patients will be enrolled and receive the same treatment as the 3rd cohort except the T-cells will be labeled with 111In and cultured ex vivo with 13C-glucose and their proliferation, persistence, and migration followed by peripheral blood sampling, Single Photon Emission Computed Tomography (SPECT ), and MRI.
After the initial 3 vaccines, patients will then receive subsequent TMZ cycles every 4 weeks for at least 6 cycles and up to 12 cycles after RT. TMZ will be given on days 1-5 of a 28 day cycle. Patients will then be imaged bimonthly and followed until death. This study will be halted if any 2 patients in any cohort of 3 experience a drug-related Grade IV or irreversible Grade III toxicity.
As part of standard care for these patients, upon tumor progression, participants may undergo stereotactic biopsy or resection. As this is not a research procedure consent will be obtained separately. However, if tissue is obtained, it will be used to confirm tumor progression histologically and to assess immunologic cell infiltration and pp65 antigen escape at the tumor site. Patients consenting to biopsy or resection will also be offered intratumoral vaccination with CMVpp65 LAMP-loaded, 111In-labeled DCs at the time of surgery to determine if they migrate to cervical lymph nodes.
- Conditions
- Glioblastoma
- Being tested
- CMV-ALT + CMV-DCs, CMV-ALT + Saline
- Keywords
- Grade IV Glioblastoma Multiforme, Newly-diagnosed, CMV positive
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV-ALT + CMV-DCsBiological
CMV-ALT (3 X 10e7) with CMV-DCs (2 X 10e7)
CMV-ALT + SalineBiological
CMV-ALT (3 X 10e7) with Saline
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CMV-ALT + CMV-DCs Receives: Biological: CMV-ALT + CMV-DCs |
| 2 | Experimental | CMV-ALT + Saline Receives: Biological: CMV-ALT + Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate if vaccinating adult patients with newly-diagnosed GBMs using CMV-DCs during recovery from therapeutic TMZ-induced lymphopenia with ALT in patients that are seropositive for CMV enhances the T-cell response.
Measured: 4 months after enrollment
Secondary outcomes (1)
To evaluate the safety of ALT with CMV pp65-activated T-cells in adult patients with newly-diagnosed GBMs during recovery from therapeutic TMZ-induced lymphopenia.
Measured: 4 months from time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2013
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Sampson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Sampson, Duke University
- Investigators
- Gordana Vlahovic, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693095
- Sponsor's protocol ID
- Pro00000580
- Other IDs
- SPORE Project 3
- Acronym
- ERaDICATe
- Status last verified
- Jan 2018
- First submitted
- 3 Jun 2008
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reap EA, Suryadevara CM, Batich KA, Sanchez-Perez L, Archer GE, Schmittling RJ, Norberg PK, Herndon JE 2nd, Healy P, Congdon KL, Gedeon PC, Campbell OC, Swartz AM, Riccione KA, Yi JS, Hossain-Ibrahim MK, Saraswathula A, Nair SK, Dunn-Pirio AM, Broome TM, Weinhold KJ, Desjardins A, Vlahovic G, McLendon RE, Friedman AH, Friedman HS, Bigner DD, Fecci PE, Mitchell DA, Sampson JH. Dendritic Cells Enhance Polyfunctionality of Adoptively Transferred T Cells That Target Cytomegalovirus in Glioblastoma. Cancer Res. 2018 Jan 1;78(1):256-264. doi: 10.1158/0008-5472.CAN-17-0469. Epub 2017 Nov 1.
PubMed 29093005
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Recovery From Drug-Induced Lymphopenia Using Cytomegalovirus-specific T-cell Adoptive Transfer
- ClinicalTrials.gov ID
- NCT00693095
- Acronym / sponsor ID
- ERaDICATe / Pro00000580
- Conditions
- Glioblastoma
- Keywords
- Grade IV Glioblastoma Multiforme, Newly-diagnosed, CMV positive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- John SampsonUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Jun 2008 (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 is to learn if your own immune cells can be activated and multiplied in order to help your body fight off the tumor cells in your brain. The safety of this procedure will also be studied. This procedure, called CMV-autologous lymphocyte transfer or CMV-ALT is investigational which means that it is not approved by the US Food and Drug Administration (FDA) and is still being tested in research studies. Autologous lymphocyte transfer or ALT means that you will receive your own immune cells back (and not from another donor) as a treatment after they have been activated and grown to large numbers in a clinical lab.
It is believed that the body's immune (protection) system can attack tumor cells and kill them. Immune cells called T-lymphocytes (T-cells) can recognize special proteins on the surface of tumors as a signal to attack and fight the cancer. In most patients with advanced cancer, the immune system does not adequately destroy the tumor because the white blood cells or T-cells are not stimulated enough.
Before your T-cells can become active against tumor cells, they require strong stimulation. There are special "stimulator" cells in the body called Dendritic Cells (DCs) that can take up proteins released from cancer cells and present pieces of these proteins to T lymphocytes to create this strong stimulation. Dendritic cells taken from your blood will be "pulsed" or loaded with genetic material called RNA (ribonucleic acid), which stimulates the DC to change the RNA into a protein called pp65. This protein is produced by a common virus called Cytomegalovirus (CMV) that 70-80% of us have been exposed to in our lifetime. Recently, we have found that this virus is present in many malignant brain tumors. Brain tumors are very aggressive and, for reasons we do not yet understand, are difficult for the body to attack. The CMV virus is a target in the tumor that, if attacked by your immune systems cells, may prevent your tumor from growing. We have found that we can grow immune cells to very large numbers from the blood of people who have evidence of prior exposure to this virus. You will therefore be tested to determine if you have pre-existing antibodies to this virus in order to participate in this study.
We will use your DCs to activate and grow immune cells from your blood to large numbers in a clinical laboratory. These CMV-specific immune cells, called CMV-ALT, will be returned to your body when they have become activated. It is hoped that these cells will seek out and kill tumor cells that express the CMV viral protein and not attack normal cells. The transfer of immune cells that stimulates your immune system is called adoptive immunotherapy. We will evaluate two doses of immune cells in this study (Dose 1 and Dose 2). Depending on when you are enrolled in this study you will receive either Dose 1 or 2. The first six patients enrolled on this study will receive Dose 1 (the lower dose) and the next six patients will receive Dose 2 (the higher dose). We do not know at this time if either dose is more effective or safer to administer which is why we are testing both doses. Dose 2 will be a larger number of immune cells if the treatment is found to be safe in the first six patients treated during this study.
In this study we will also see, in some randomly selected patients, if giving an injection of the DC pulsed with pp65 RNA into the skin improves the function of the CMV-ALT treatment or not. You will receive three injections under the skin of either some of the same DC that were used to stimulate your immune cells in the clinical laboratory or three injections of saline (salt solution) under the skin starting with the infusion of the CMV-ALT. It is unknown if a DC injection will be beneficial to the immune cells or not so the responses will be compared in patients who receive DC versus saline injection with their CMV-ALT. After these three injections, blood will be collected to compare the responses between patients that received saline to those that received DC injections.
Detailed description
Six CMV seropositive patients with newly-diagnosed GBM will be randomized to receive CMV-ALT (3 x 107/Kg) with or without vaccine with CMV-DCs (2 x 107). All patients will undergo a leukapheresis after resection for harvest of PBLs for CMV-ALT and CMV-DC generation. Patients will then receive RT and concurrent TMZ at a standard targeted dose of 75 mg/m2/d. Patients with histologically or clinically-proven progressive disease during radiation, dependent on steroid supplements above physiologic levels at time of vaccination, and are unable to tolerate TMZ will be replaced. If sufficient CMV-specific T-cells can't be expanded or ALT doesn't meet release criteria, the patient will be replaced and their cells may be used to offer them another DC vaccination study, such as ATTAC Pro00003877. Remaining patients will then receive the initial cycle of TMZ at a standard targeted dose of 200mg/m2/d for 5 days 3 + 1 weeks after completing RT and will be randomized to receive CMV-DCs or saline simultaneous with CMV-ALT as vaccine #1. While the standard targeted dose of 200mg/m2/d for 5 days TMZ treatment is recommended, TMZ regimen may be adjusted at the discretion of the treating neuro-oncologist. Patients with MRI changes consistent with pseudoprogression who continue on TMZ will receive CMV-ALT with vaccinations as scheduled. Peripheral blood will be drawn at 0 hours, 24 hours, 48 hours, 72 hours, and 1 week post vaccine #1 for T-cell kinetics. DCs or saline will be given intradermally and divided equally to both inguinal regions. Vaccines #2 and #3 will occur at 2 week intervals. All patients will then undergo leukapheresis again for immunologic monitoring with specific assessment of baseline antigen-specific cellular and humoral immune responses.
If the initial dose of CMV-ALT is safe and the combination of CMV-DCs is safe and does not produce an inferior CMV pp65-specific immune response, a 3rd cohort of patients will be enrolled and receive a higher dose of CMV-ALT (3 x 108/Kg) along with vaccine with CMV-DCs (2 x 107). If the combination is unsafe or inferior only the CMV-ALT will be given. If CMV-ALT (3 x 108/Kg) is safe a 4th cohort of 3 patients will be enrolled and receive the same treatment as the 3rd cohort except the T-cells will be labeled with 111In and cultured ex vivo with 13C-glucose and their proliferation, persistence, and migration followed by peripheral blood sampling, Single Photon Emission Computed Tomography (SPECT ), and MRI.
After the initial 3 vaccines, patients will then receive subsequent TMZ cycles every 4 weeks for at least 6 cycles and up to 12 cycles after RT. TMZ will be given on days 1-5 of a 28 day cycle. Patients will then be imaged bimonthly and followed until death. This study will be halted if any 2 patients in any cohort of 3 experience a drug-related Grade IV or irreversible Grade III toxicity.
As part of standard care for these patients, upon tumor progression, participants may undergo stereotactic biopsy or resection. As this is not a research procedure consent will be obtained separately. However, if tissue is obtained, it will be used to confirm tumor progression histologically and to assess immunologic cell infiltration and pp65 antigen escape at the tumor site. Patients consenting to biopsy or resection will also be offered intratumoral vaccination with CMVpp65 LAMP-loaded, 111In-labeled DCs at the time of surgery to determine if they migrate to cervical lymph nodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: CMV-ALT + CMV-DCsCMV-ALT + CMV-DCs |
| 2 | Experimental | Biological: CMV-ALT + SalineCMV-ALT + Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years of age.
- GBM (WHO Grade IV) with definitive resection <4 weeks prior to leukapheresis with residual radiographic contrast enhancement on post-resection CT or MRI of <1 cm in maximal diameter in any axial plane.
- Karnofsky Performance Status (KPS ) of > 80% and a Curran Group status of I-IV.
Key exclusion criteria (9 listed)
- Radiographic or cytologic evidence of leptomeningeal or multicentric disease at any time prior to vaccination.
- Prior conventional anti-tumor therapy other than steroids, RT, or TMZ.
- Pregnant or need to breast feed during the study period (Negative b-HCG test required).
- Requirement for continuous corticosteroids above physiologic levels at time of first vaccination.
- Active infection requiring treatment or an unexplained febrile (> 101.5o F) illness.
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 |
|---|---|---|
| CMV-ALT + CMV-DCsCMV-ALT (3 X 10e7) with CMV-DCs (2 X 10e7) | Biological | 1 |
| CMV-ALT + SalineCMV-ALT (3 X 10e7) with Saline | Biological | 2 |
Primary outcome
To evaluate if vaccinating adult patients with newly-diagnosed GBMs using CMV-DCs during recovery from therapeutic TMZ-induced lymphopenia with ALT in patients that are seropositive for CMV enhances the T-cell response.
Time frame: 4 months after enrollment
1 secondary outcome
To evaluate the safety of ALT with CMV pp65-activated T-cells in adult patients with newly-diagnosed GBMs during recovery from therapeutic TMZ-induced lymphopenia.
Time frame: 4 months from time of enrollment
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 30 Jan 2018.
- Background: PubMed 29093005Reap EA, Suryadevara CM, Batich KA, Sanchez-Perez L, Archer GE, Schmittling RJ, Norberg PK, Herndon JE 2nd, Healy P, Congdon KL, Gedeon PC, Campbell OC, Swartz AM, Riccione KA, Yi JS, Hossain-Ibrahim MK, Saraswathula A, Nair SK, Dunn-Pirio AM, Broome TM, Weinhold KJ, Desjardins A, Vlahovic G, McLendon RE, Friedman AH, Friedman HS, Bigner DD, Fecci PE, Mitchell DA, Sampson JH. Dendritic Cells Enhance Polyfunctionality of Adoptively Transferred T Cells That Target Cytomegalovirus in Glioblastoma. Cancer Res. 2018 Jan 1;78(1):256-264. doi: 10.1158/0008-5472.CAN-17-0469. Epub 2017 Nov 1.
- Brain Tumor Center of Duke University Medical CenterLink 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.
Gordana Vlahovic, MD principal investigator
Duke University
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 CMV-ALT + CMV-DCs and CMV-ALT + Saline in people with Glioblastoma, run by John Sampson 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 3 inclusion and 9 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 30 Jan 2018. 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?
To evaluate if vaccinating adult patients with newly-diagnosed GBMs using CMV-DCs during recovery from therapeutic TMZ-induced lymphopenia with ALT in patients that are seropositive for CMV enhances the T-cell response. (time frame: 4 months after enrollment). 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 NCT00693095, which also lists 1 linked publication.
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 30 Jan 2018.