GlioblastomaPhase 2I-ATTACNCT03927222

Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma

A Phase 2 study testing Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF, Temozolomide and Tetanus-Diphtheria Toxoid (Td) in people with Glioblastoma, run by Mustafa Khasraw, MBChB, MD, FRCP, FRACP at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Glioblastoma
What is being tested?: Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF, Temozolomide and Tetanus-Diphtheria Toxoid (Td)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 30 Sep 2019to 10 Feb 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Newly diagnosed World Health Organization (WHO) Grade IV Glioma with definitive resection prior to the consent, with a residual radiographic contrast enhancing disease on the postoperative computed tomography (CT) or Magnetic Resonance Imaging (MRI) of <1 cm in maximal diameter in any plane.
Able to receive standard of care radiation and chemotherapy for approximately 6 weeks duration and of more than 54 Gray (GY)
MRI post radiation therapy (RT) does not show progressive disease outside the radiation field
Enough tumor tissue available for determination of methylguanine-DNA methyltransferase (MGMT) gene promoter status (must be unmethylated) or prior pathology report available confirming MGMT gene promoter status
Cytomegalovirus (CMV) Seropositive

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Karnofsky Performance Status (KPS) of ≥ 70%
Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,000 cells/µl, platelets ≥ 100,000 cells/µl prior to starting TMZ cycle 1 (patient must meet these criteria within 4 weeks after the end of XRT/TMZ to be eligible)
Serum creatinine ≤ 3 times institutional upper limit of normal (ULN) for age, aspartate aminotransferase (AST) ≤ 3 times institutional upper limit of normal for age
Bilirubin ≤ 1.5 times upper limit of normal prior to starting TMZ cycle 1 (Exception: Patient has known Gilbert's Syndrome or patient has suspected Gilbert's Syndrome, for which additional lab testing of direct and/or indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)
Signed informed consent approved by the Institutional Review Board
Female patients must not be pregnant or breastfeeding. Female patients of childbearing potential (defined as < 2 years after last menstruation or not surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control, [i.e. with a failure rate of < 1% per year] are implants, injectables, combined oral contraceptives, intrauterine device [IUD; only hormonal], sexual abstinence or vasectomized partner) during the trial and for a period of > 6 months following the last administration of trial drug(s). Female patients with an intact uterus (unless amenorrhea for the last 24 months) must have a negative serum pregnancy test within 48 hours prior to first study procedure (leukapheresis).
Fertile male patients must agree to use a highly effective contraceptive method (allowed methods of birth control [i.e. with a failure rate of < 1% per year] include a female partner using implants, injectables, combined oral contraceptives, intrauterine devices (IUDs) [only hormonal], sexual abstinence or prior vasectomy) during the trial and for a period of > 6 months following the last administration of trial drugs.

Who cannot join

Pregnant or breastfeeding.
Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
Patients with known potentially anaphylactic allergic reactions to gadolinium- diethylenetriamine penta-acetic acid (DTPA).
Patients who cannot undergo MRI or SPECT due to obesity or to having certain metal in their bodies (specifically pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates).
Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, radiological evidence of multifocal disease, or leptomeningeal disease.
Severe, active comorbidity, including any of the following:

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Unstable angina and/or congestive heart failure requiring hospitalization;
Transmural myocardial infarction within the last 6 months;
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study initiation;
Chronic obstructive pulmonary disease exacerbation or other respiratory illness r requiring hospitalization or precluding study therapy;
Known hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
Known Human Immunodeficiency Virus (HIV) and Hepatitis C positive status;
Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy;
Active connective tissue disorders, such as lupus or scleroderma that, in the opinion of the treating physician, may put the patient at high risk for radiation toxicity.
Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin. (Treatment with tamoxifen or aromatase inhibitors or other hormonal therapy that may be indicated in the prevention of prior cancer disease recurrence, are not considered current active treatment.)
Patients are not permitted to have had any other conventional therapeutic intervention other than steroids prior to enrollment outside of the standard of care chemotherapy and radiation therapy. Patients who receive previous inguinal lymph node dissection, radiosurgery, brachytherapy, or radiolabeled monoclonal antibodies will be excluded
Current, recent (within 4 weeks of the administration of this study agent), or planned participation in an experimental drug study.
Known history of autoimmune disease (with the exceptions of medically-controlled hypothyroidism and Type I Diabetes Mellitus).

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: I-ATTAC: Improved Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma

This single-arm phase II study will assess the impact of tetanus pre-conditioning and adjuvant Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) on overall survival of patients newly diagnosed with World Health Organization (WHO) Grade IV glioblastoma who have undergone definitive tumor resection, are cytomegalovirus (CMV) positive and unmethylated, and completed standard temozolomide (TMZ) and radiation treatment. After completion of the standard of care radiotherapy with concurrent TMZ, patients will receive 1 cycle of dose-intensified TMZ followed by pp65-loaded dendritic cell (DC) vaccination beginning on day 23.

Read the detailed description

Approximately 64 patients with resected, newly-diagnosed WHO Grade IV glioma who are CMV positive and in which the Methylguanine Methyltransferase (MGMT) is not methylated will be accrued to this study before standard of care radiation therapy (RT) and concurrent TMZ, with the goal of treating 48 patients with dose-intensified temozolomide and pp65 loaded dendritic cell vaccine after completion of standard RT and TMZ.

All enrolled patients will undergo a leukapheresis for the generation of DCs. Patients will then receive approximately 6 weeks of the standard of care radiation therapy (RT) and concurrent TMZ at a standard targeted dose of 75 mg/m2/day. For patients whose initial leukapheresis yields less than 3 vaccines, repeat leukapheresis may be obtained. At the post-RT clinic visit, a single post-RT cycle of dose-intensified TMZ (100 mg/m2/day for 21 days) will be given. On day 23 (± 2 days) of the cycle, patients will receive the first of 3 pp65 DC vaccines. Vaccines #1-3 will be given every two weeks (± 2 days). All patients will receive up to a total of 10 DC vaccines, with vaccines administered every 35 days (± 7 days) after the third vaccine, given bilaterally at the groin site unless progression occurs with no further cycles of TMZ. DC vaccines will be given intradermally (i.d.) and divided equally to both inguinal regions. Before the first DC vaccination, patients will receive 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Patients will undergo leukapheresis again for immunologic monitoring with a specific assessment of baseline antigen-specific cellular and humoral immune responses if needed for further DC generations 14 (± 2) days after vaccine #3. Prior to pp65 DC vaccination #4,(3±1) weeks after leukapheresis 2, the vaccine site will receive a pre-conditioning intradermal injection of Td. Up to 16 patients will receive 111-Indium labeled DCs at the 4th vaccine followed by SPECT/CT imaging immediately, and at 1 and 2 days after injections.

Conditions: Glioblastoma
Being tested: Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF, Temozolomide, Tetanus-Diphtheria Toxoid (Td), GM-CSF, 111-Indium-labeling of Cells for in vivo Trafficking Studies
Keywords: Glioblastoma, Dendritic cells, Temozolomide, Tetanus, Khasraw, Immunotherapy, Vaccine
Medical subject headings: Glioblastoma, Tetanus

What participants receive

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

Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSFBiological
Also called CMV-specific dendritic cell vaccine, DCs
2x10^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions). Patients will receive up to a total of 10 DC vaccines.
TemozolomideDrug
Also called Temodar, TMZ, Temodal
Temozolomide is a chemotherapy drug given to all enrolled patients at the post-RT clinic visit as dose-intensified TMZ (100 mg/m2/day for 21 days).
Tetanus-Diphtheria Toxoid (Td)Biological
Also called Td pre-conditioning, Td toxoid
Before the first DC vaccination, patients will receive 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Prior to pp65 DC vaccination #4,(3±1) weeks after leukapheresis 2 the vaccine site will receive a pre-conditioning intradermal injection of Td (1 flocculation unit (Lf), in 0.3 mL of saline for a total of 0.4 mL).
GM-CSFBiological
Also called LEUKINE®, Sargramostim
Granulocyte macrophage-colony stimulating factor (GM-CSF) is a sterile, white, preservative-free lyophilized powder in a vial containing 250 mcg that will be reconstituted in 0.5 mL of sterile water for injection and used as an adjuvant with the DC vaccine.
111-Indium-labeling of Cells for in vivo Trafficking StudiesBiological
111-In-labeled DCs are 2 x 10^7 pp65-LAMP mRNA loaded mature DCs labeled with 111-In (50 μCi / 5 x 10^7 DCs) and given i.d. as the fourth vaccine. In up to 16 patients, the fourth vaccine will be labeled with 111-In (50 μCi / 5 x 10^7 DCs) prior to injection.

Study groups in NCT03927222
Study group	Role	What they receive
DC vaccination with Td preconditioning and GM CSF	Experimental	This single-arm phase II study will assess the impact of tetanus pre-conditioning and adjuvant GM-CSF on overall survival of newly diagnosed glioblastoma (GBM) patients who have undergone definitive resection, are unmethylated, and completed standard temozolomide and radiation treatment. All enrolled patients will undergo a leukapheresis for the generation of DCs. Patients will then receive approximately 6 weeks of standard of care radiation therapy (RT) and concurrent TMZ. A single post-RT cycle of dose intensified TMZ (100 mg/m2/day for 21 days) will then be given. On day 23 (± 2 days) of the cycle, patients will receive the first of 3 pp65 DC vaccines every 2 weeks. All patients will receive up to a total of 10 DC vaccines Receives: Biological: Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF; Drug: Temozolomide; Biological: Tetanus-Diphtheria Toxoid (Td); Biological: GM-CSF; Biological: 111-Indium-labeling of Cells for in vivo Trafficking Studies

What is being measured

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

Median Overall Survival (OS) of Subjects Receiving Td Pre-conditioning With GM-CSF
Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up has OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Measured: duration of the study (up to 3 years and 4.5 months)

Secondary outcomes (5)

Migration and Survival From Vaccine 4
The Cox proportional hazards model will assess the impact of migration on survival after vaccine #4. Migration is defined as the maximum percentage of 111In-labeled dendritic cells (DCs) reaching inguinal nodes during the 48 hours after the 4th vaccination. The hazard ratio associated with a 1-unit change in migration will be estimated with 95% confidence intervals.CSF to site-draining inguinal lymph nodes after Td pre-conditioning and survival after vaccine # 4.
Measured: 5 years
Chemokine (C-C Motif) Ligand 3 (CCL3) and Survival From Vaccine 4
The Cox proportional hazards model will assess the impact of CCL3 on survival post-vaccine 4. The hazard ratio associate with a 1-unit increase in CCL3 will be estimated with 95% confidence intervals
Measured: 5 years
Polyfunctionality and Survival From Vaccine 4
Cox proportional hazards model will assess the association between fold change increase between baseline and the leukapheresis 2 in the frequency of pp65 antigen-specific CD8+ T cells producing three or more cytokines (IFNγ, CCL3, IL-2, TNFα, CD107a), and survival post-vaccine 4. The hazard ratio associate with a 1-unit fold change in polyfunctionality will be estimated with 95% confidence intervals.
Measured: 5 years
Maximum Peak Increase From Vaccine 1 in Percent Regulatory T Cells (TReg) of CD4+ T Cells
The mean difference in TRegs between vaccine 1 and the maximum measured level post-vaccine 1 will be reported.
Measured: 1 year
Number of Participants With Unacceptable Toxicity
An unacceptable toxicity is defined as any grade 3 or greater toxicity that is possibly, probably, or definitely attributed to the pre-conditioning agent Td or pp65 DC vaccine that does not resolve to baseline within 3 weeks; any Grade 3 hypersensitivity reactions or autoimmune toxicity requiring steroids or hormone replacement; , and is not due to progressive disease, or any life-threatening event not attributable to concomitant medication, co-morbid event, or disease progression. Toxicities will be graded according to the National Cancer Institute Common Toxicity Criteria of Adverse Events (NCI CTCAE) version 5 criteria.
Measured: 1 year

Timeline

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

30 Sep 201910 Feb 2023

First posted25 Apr 2019
Study start30 Sep 2019
Primary completion10 Feb 2023
Study completion10 Feb 2023

Why it stopped: Resource shortage

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Newly-diagnosed WHO Grade IV glioma patients with their tumor resected and found to be MGMT unmethylated will be accrued to this study before the standard of care chemoradiation with the goal of treating with dose-intensified TMZ and pp65 loaded dendritic cell vaccine after completion of the standard of care chemoradiation.
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03927222
Sponsor's protocol ID: Pro00090683
Acronym: I-ATTAC
Status last verified: Apr 2024
First submitted: 19 Apr 2019
Last updated: 8 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
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RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
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Glioma, Medulloblastoma

All Glioblastoma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: I-ATTAC: Improved Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma
ClinicalTrials.gov ID: NCT03927222
Acronym / sponsor ID: I-ATTAC / Pro00090683
Conditions: Glioblastoma
Keywords: Glioblastoma, Dendritic cells, Temozolomide, Tetanus, Khasraw, Immunotherapy, Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Resource shortage
Enrolment: 6 participants (actual)
Lead sponsor: Mustafa Khasraw, MBChB, MD, FRCP, FRACPUniversity, hospital or other
Study start: 30 Sep 2019 (actual)
Primary completion: 10 Feb 2023 (actual)
Study completion: 10 Feb 2023 (actual)
First posted: 25 Apr 2019 (actual)
Results: Posted 8 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Newly-diagnosed WHO Grade IV glioma patients with their tumor resected and found to be MGMT unmethylated will be accrued to this study before the standard of care chemoradiation with the goal of treating with dose-intensified TMZ and pp65 loaded dendritic cell vaccine after completion of the standard of care chemoradiation.

Arm	Type	Receives
DC vaccination with Td preconditioning and GM CSF	Experimental	Biological: Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF, Drug: Temozolomide, Biological: Tetanus-Diphtheria Toxoid (Td), Biological: GM-CSF, Biological: 111-Indium-labeling of Cells for in vivo Trafficking StudiesThis single-arm phase II study will assess the impact of tetanus pre-conditioning and adjuvant GM-CSF on overall survival of newly diagnosed glioblastoma (GBM) patients who have undergone definitive resection, are unmethylated, and completed standard temozolomide and radiation treatment. All enrolled patients will undergo a leukapheresis for the generation of DCs. Patients will then receive approximately 6 weeks of standard of care radiation therapy (RT) and concurrent TMZ. A single post-RT cycle of dose intensified TMZ (100 mg/m2/day for 21 days) will then be given. On day 23 (± 2 days) of the cycle, patients will receive the first of 3 pp65 DC vaccines every 2 weeks. All patients will receive up to a total of 10 DC vaccines

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Age ≥ 18 years
Newly diagnosed World Health Organization (WHO) Grade IV Glioma with definitive resection prior to the consent, with a residual radiographic contrast enhancing disease on the postoperative computed tomography (CT) or Magnetic Resonance Imaging (MRI) of <1 cm in maximal diameter in any plane.
Able to receive standard of care radiation and chemotherapy for approximately 6 weeks duration and of more than 54 Gray (GY)
MRI post radiation therapy (RT) does not show progressive disease outside the radiation field
Enough tumor tissue available for determination of methylguanine-DNA methyltransferase (MGMT) gene promoter status (must be unmethylated) or prior pathology report available confirming MGMT gene promoter status

Key exclusion criteria (19 listed)

Pregnant or breastfeeding.
Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
Patients with known potentially anaphylactic allergic reactions to gadolinium- diethylenetriamine penta-acetic acid (DTPA).
Patients who cannot undergo MRI or SPECT due to obesity or to having certain metal in their bodies (specifically pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates).
Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, radiological evidence of multifocal disease, or leptomeningeal disease.

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
Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSFAlso: CMV-specific dendritic cell vaccine, DCs2x10^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions). Patients will receive up to a total of 10 DC vaccines.	Biological	DC vaccination with Td preconditioning and GM CSF
TemozolomideAlso: Temodar, TMZ, TemodalTemozolomide is a chemotherapy drug given to all enrolled patients at the post-RT clinic visit as dose-intensified TMZ (100 mg/m2/day for 21 days).	Drug	DC vaccination with Td preconditioning and GM CSF
Tetanus-Diphtheria Toxoid (Td)Also: Td pre-conditioning, Td toxoidBefore the first DC vaccination, patients will receive 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Prior to pp65 DC vaccination #4,(3±1) weeks after leukapheresis 2 the vaccine site will receive a pre-conditioning intradermal injection of Td (1 flocculation unit (Lf), in 0.3 mL of saline for a total of 0.4 mL).	Biological	DC vaccination with Td preconditioning and GM CSF
GM-CSFAlso: LEUKINE®, SargramostimGranulocyte macrophage-colony stimulating factor (GM-CSF) is a sterile, white, preservative-free lyophilized powder in a vial containing 250 mcg that will be reconstituted in 0.5 mL of sterile water for injection and used as an adjuvant with the DC vaccine.	Biological	DC vaccination with Td preconditioning and GM CSF
111-Indium-labeling of Cells for in vivo Trafficking Studies111-In-labeled DCs are 2 x 10^7 pp65-LAMP mRNA loaded mature DCs labeled with 111-In (50 μCi / 5 x 10^7 DCs) and given i.d. as the fourth vaccine. In up to 16 patients, the fourth vaccine will be labeled with 111-In (50 μCi / 5 x 10^7 DCs) prior to injection.	Biological	DC vaccination with Td preconditioning and GM CSF

Primary outcome

Median Overall Survival (OS) of Subjects Receiving Td Pre-conditioning With GM-CSF
Time frame: duration of the study (up to 3 years and 4.5 months)
Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up has OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.

5 secondary outcomes

Migration and Survival From Vaccine 4
Time frame: 5 years
Chemokine (C-C Motif) Ligand 3 (CCL3) and Survival From Vaccine 4
Time frame: 5 years
Polyfunctionality and Survival From Vaccine 4
Time frame: 5 years
Maximum Peak Increase From Vaccine 1 in Percent Regulatory T Cells (TReg) of CD4+ T Cells
Time frame: 1 year
Number of Participants With Unacceptable Toxicity
Time frame: 1 year

Results and safety

Results posted to the registry on 8 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DC Vaccination With Td Preconditioning and GM CSF	6	0

Primary outcome: Median Overall Survival (OS) of Subjects Receiving Td Pre-conditioning With GM-CSF

Time frame: duration of the study (up to 3 years and 4.5 months). Median (95% Confidence Interval). Unit: months

Measure	DC Vaccination With Td Preconditioning and GM CSF n = 6
Value	17.4 (13.3 to NA)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of the study (up to 3 years and 4.5 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DC Vaccination With Td Preconditioning and GM CSF	0 of 6 (0%)	6 of 6 (100%)	5 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
The Preston Robert Tisch Brain Tumor Center at DukeLink provided by the sponsor.
Duke Cancer InstituteLink provided by the sponsor.
Duke HealthLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Glioblastoma

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EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
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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.

Mustafa Khasraw, MBChB, MD, FRCP, FRACP 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?

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 13 inclusion and 19 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 8 Apr 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Median Overall Survival (OS) of Subjects Receiving Td Pre-conditioning With GM-CSF (time frame: duration of the study (up to 3 years and 4.5 months)). 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 NCT03927222.

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 8 Apr 2024.