CompletedNCT02465268ATTAC-IIUpdated Jan 14, 2025Results posted

Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme

A Phase 2 interventional study of pp65-shLAMP DC with GM-CSF and unpulsed PBMC and saline in Glioblastoma Multiforme, Glioblastoma and Malignant Glioma, sponsored by University of Florida. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by University of Florida · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 175
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this research study is to determine if an investigational dendritic cell vaccine, called pp65 DC, is effective for the treatment of a specific type of brain tumor called glioblastoma (GBM) when given with stronger doses of routine chemotherapy.

Read the detailed description

Dendritic cells (DC) are involved in activating, or turning-on, your body's immune system. Your immune system helps guard your body from germs, viruses, and other threats. Although dendritic cells are very strong, the number of them in the body is not high enough to cause a powerful immune response; therefore, more DC are made in a laboratory with cells collected from an individual's blood.

In this study, we will make a vaccine that we hope will educate immune cells to target the pp65 antigen, a type of immune marker in GBM, thus resulting in what we call the pp65 DC vaccine. Use of a vaccine that activates your immune system is a type of immunotherapy. It is hoped that by giving the pp65 DC vaccine as a shot under the skin, the immune system will be activated to attack tumor cells in the brain while leaving normal cells alone.

To see if the pp65 DC vaccine is effective for the treatment of GBM, subjects will be assigned to different treatment groups. Two groups of subjects will receive the pp65 DC vaccine and one group will receive a placebo.

Conditions studied

Glioblastoma Multiforme
Glioblastoma
Malignant Glioma
Astrocytoma, Grade IV
GBM

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In context

Glioblastoma

1,919 studies on the registry are indexed under Glioblastoma; 449 are open to participants now.

This study's enrollment of 175 is above the median of 36 across 1,617 interventional studies indexed under Glioblastoma.

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Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Abbreviated Inclusion Criteria:

To be assessed at study enrollment prior to standard of care chemo-radiation therapy:

Age ≥ 18 years.
Histopathologically proven newly-diagnosed de novo GBM (WHO Grade IV glioma)
The tumor must have a supratentorial component.
Must have undergone definitive surgical resection of tumor with less than approximately 3cm x 3cm residual enhancing tumor as product of longest perpendicular planes by MRI.
Recovery from the effects of surgery, postoperative infection, and other complications.
Diagnostic contrast-enhanced MRI or CT scan of the brain preoperatively and postoperatively.
Karnofsky Performance Status of ≥ 70.
Signed informed consent.
For females of childbearing potential, negative serum pregnancy test.
Women of childbearing potential and male participants must be willing to practice adequate contraception throughout the study and for at least 24 weeks after the last dose of study drug.

To be assessed prior to initiation of adjuvant TMZ:

Must have completed RT (targeted total dose of 59.4-60.0 Gy over ≤ 7 weeks) and concomitant TMZ (targeted dose of 75mg/m2/d for ≤ 49 days) therapy without significant toxicity that persisted over 4 weeks.
History \& physical with neurologic examination prior to initiation of adjuvant TMZ.
For patients receiving steroids, daily dose must be ≤ 4 mg.
CBC with differential with adequate bone marrow function.
Adequate renal function.
Adequate hepatic function.

Abbreviated Exclusion Criteria:

To be verified in order to randomize subject:

Prior invasive malignancy unless disease free for ≥ 3 years.
Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.
Recurrent or multifocal malignant gliomas.
HIV, Hepatitis B, or Hepatitis C seropositive.
Known active infection or immunosuppressive disease.
Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region.
Prior radiotherapy to the head or neck, resulting in overlap of radiation fields.
Severe, active co-morbidity.
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period.
Pregnant or lactating women.
Prior allergic reaction to temozolomide, GM-CSF or Td.
Prior history of brachial neuritis or Guillain-Barré syndrome.
Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry.

To be assessed prior to initiation of adjuvant TMZ:

Did not start radiation therapy and temozolomide within 7 weeks of surgery.
Progression of disease as defined by modified RANO criteria.
More than 45 days after completion of radiation therapy and temozolomide

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 175 participants (actual)

Study arms

Experimental
Arm 1: pp65-shLAMP DC with GM-CSF and Td
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
Biological: pp65-shLAMP DC with GM-CSF · Drug: Td
Experimental
Arm 2: pp65-flLAMP DC with GM-CSF and Td
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
Drug: Td · Biological: pp65-flLAMP DC with GM-CSF
Placebo comparator
Arm 3: unpulsed PBMC and Saline
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
Biological: unpulsed PBMC and saline · Drug: Saline

Interventions

Biologicalpp65-shLAMP DC with GM-CSF
Also known as: pp65-shLAMP mRNA DCs with GM-CSF
Biologicalunpulsed PBMC and saline
Also known as: Peripheral Blood Mononuclear Cells
DrugTd
All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
Also known as: Tetanus and Diphtheria Toxoid
DrugSaline
Also known as: Normal Saline
Biologicalpp65-flLAMP DC with GM-CSF
Also known as: pp65-flLAMP mRNA DCs with GM-CSF

What researchers measure

Primary outcomes

Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3)
Kaplan-Meier survival curves and the log rank test will be used to characterize and compare OS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). OS will be defined as the time between first vaccination and death and will be censored at the last follow-up if death has not occurred.
Time frame: From date of first vaccine until the date of death, up to 48 months

Secondary outcomes

Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3)
Calculated as dated of first vaccine to date first progression/recurrence or death. Kaplan-Meier survival curves and the log rank test will be used to characterize and compare PFS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). PFS is defined as the time between first vaccination and first documentation of either disease progression/recurrence, or death without prior progression/recurrence.
Time frame: From date of first vaccine until time disease progression or death without prior progression/recurrence, up to 48 months
ELISPOT Assay (pp65)
Within patient changes from baseline to vaccine 3.
Time frame: baseline, post-vaccine #3
Flow Cytometric Analysis (T Cell)
Percentage of circulating cellular subsets of T cells within PBMCs.
Time frame: baseline, post-vaccine #3
Cytokine Array Analysis (IFN-g)
Change in concentration (pg/mL) of IFN-g as measured by multiplex array from Baseline (V1) to post-Vaccine #3.
Time frame: baseline, post-vaccine #3
ELISPOT Assay (Actin)
Within patient changes from baseline to vaccine 3.
Time frame: baseline, post-vaccine #3
Flow Cytometric Analysis (NK Cell)
Percentage of circulating cellular subsets of NK cells within PBMCs.
Time frame: baseline, post-vaccine #3
Flow Cytometric Analysis (CD4.CD25 T Reg)
Percentage of circulating cellular subsets of CD4.CD25 T Reg within PBMCs.
Time frame: baseline, post-vaccine #3

Results

Posted Jan 14, 2025

Participant flow

175 participants were enrolled (consented) between 8/9/2016 and 10/5/2022.

Participant flow — Overall Study
Milestone	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)
Started	52	50	52
Completed	36	34	41
Not completed	16	16	11
Withdrew: Withdrawal by subject	4	3	1
Withdrew: Not evaluable per protocol criteria	3	2	1
Withdrew: Did not meet eligibility prior to cycle #1	8	9	9
Withdrew: Study drug did not pass qa/qc	1	0	0
Withdrew: Adverse event	0	1	0
Withdrew: Physician decision	0	1	0

Outcome measures

PrimaryComparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3)

Kaplan-Meier survival curves and the log rank test will be used to characterize and compare OS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). OS will be defined as the time between first vaccination and death and will be censored at the last follow-up if death has not occurred.

Time frame:: From date of first vaccine until the date of death, up to 48 months
Reported as:: Median · months

Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3)
months	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)
Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3)	16.9 (12.7 to 22.8)	16.2 (13.8 to 19.2)	20.6 (15.4 to 30.2)

Statistical analysis

pp65-shLAMP DC With GM-CSF and Td (Arm 1) vs Unpulsed PBMC and Saline (Arm 3) · Log Rank · p = 0.196 · Hazard ratio (hr): 1.29 · 95% CI 0.77 to 2.16
pp65-flLAMP DC With GM-CSF and Td (Arm 2) vs Unpulsed PBMC and Saline (Arm 3) · Log Rank · p = 0.196 · Hazard ratio (hr): 1.63 · 95% CI 0.99 to 2.70

SecondaryComparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3)

Calculated as dated of first vaccine to date first progression/recurrence or death. Kaplan-Meier survival curves and the log rank test will be used to characterize and compare PFS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). PFS is defined as the time between first vaccination and first documentation of either disease progression/recurrence, or death without prior progression/recurrence.

Time frame:: From date of first vaccine until time disease progression or death without prior progression/recurrence, up to 48 months
Reported as:: Median · months

Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3)
months	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	Plus pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)
Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3)	6.1 (3.9 to 11.0)	6.4 (4.2 to 10.8)	7.1 (3.9 to 14.8)

Statistical analysis

pp65-shLAMP DC With GM-CSF and Td (Arm 1) vs Unpulsed PBMC and Saline (Arm 3) · Log Rank · p = 0.354 · Hazard ratio (hr): 0.98 · 95% CI 0.60 to 1.61
Plus pp65-flLAMP DC With GM-CSF and Td (Arm 2) vs Unpulsed PBMC and Saline (Arm 3) · Log Rank · p = 0.354 · Hazard ratio (hr): 1.42 · 95% CI 0.87 to 2.33

SecondaryELISPOT Assay (pp65)

Within patient changes from baseline to vaccine 3.

Time frame:: baseline, post-vaccine #3
Reported as:: Mean · spot forming units (SFU)

ELISPOT Assay (pp65)
spot forming units (SFU)	Arm 1: pp65-shLAMP DC With GM-CSF and Td	Arm 2: pp65-flLAMP DC With GM-CSF and Td	Arm 3: Unpulsed PBMC and Saline
ELISPOT Assay (pp65)	126.3 ± 759.9	48.4 ± 377.5	-162.7 ± 1075.4

Statistical analysis

Arm 1: pp65-shLAMP DC With GM-CSF and Td · Kruskal-Wallis · p = 0.038
Arm 2: pp65-flLAMP DC With GM-CSF and Td · Kruskal-Wallis · p = 0.038
Arm 3: Unpulsed PBMC and Saline · Kruskal-Wallis · p = 0.038

SecondaryFlow Cytometric Analysis (T Cell)

Percentage of circulating cellular subsets of T cells within PBMCs.

Time frame:: baseline, post-vaccine #3
Reported as:: Mean · percentage of PBMC

Flow Cytometric Analysis (T Cell)
percentage of PBMC	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)
Flow Cytometric Analysis (T Cell)	-0.1 ± 11.1	5.9 ± 16.6	1.7 ± 7.0

SecondaryCytokine Array Analysis (IFN-g)

Change in concentration (pg/mL) of IFN-g as measured by multiplex array from Baseline (V1) to post-Vaccine #3.

Time frame:: baseline, post-vaccine #3
Reported as:: Mean · pg/mL

Cytokine Array Analysis (IFN-g)
pg/mL	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)
Cytokine Array Analysis (IFN-g)	-3.5 ± 5.0	3.3 ± 17.7	-1.7 ± 10.0

Statistical analysis

pp65-shLAMP DC With GM-CSF and Td (Arm 1) · Kruskal-Wallis · p = 0.2
pp65-flLAMP DC With GM-CSF and Td (Arm 2) · Kruskal-Wallis · p = 0.2
Unpulsed PBMC and Saline (Arm 3) · Kruskal-Wallis · p = 0.2

SecondaryELISPOT Assay (Actin)

Within patient changes from baseline to vaccine 3.

Time frame:: baseline, post-vaccine #3
Reported as:: Mean · spot forming units (SFU)

ELISPOT Assay (Actin)
spot forming units (SFU)	Arm 1: pp65-shLAMP DC With GM-CSF and Td	Arm 2: pp65-flLAMP DC With GM-CSF and Td	Arm 3: Unpulsed PBMC and Saline
ELISPOT Assay (Actin)	0.4 ± 6.0	-0.2 ± 26.1	-0.4 ± 9.4

Statistical analysis

Arm 1: pp65-shLAMP DC With GM-CSF and Td · Kruskal-Wallis · p = 0.6
Arm 2: pp65-flLAMP DC With GM-CSF and Td · Kruskal-Wallis · p = 0.6
Arm 3: Unpulsed PBMC and Saline · Kruskal-Wallis · p = 0.6

SecondaryFlow Cytometric Analysis (NK Cell)

Percentage of circulating cellular subsets of NK cells within PBMCs.

Time frame:: baseline, post-vaccine #3
Reported as:: Mean · percentage of PBMC

Flow Cytometric Analysis (NK Cell)
percentage of PBMC	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)
Flow Cytometric Analysis (NK Cell)	-1.3 ± 11.1	5.9 ± 16.6	1.7 ± 7.0

SecondaryFlow Cytometric Analysis (CD4.CD25 T Reg)

Percentage of circulating cellular subsets of CD4.CD25 T Reg within PBMCs.

Time frame:: baseline, post-vaccine #3
Reported as:: Mean · percentage of PBMC

Flow Cytometric Analysis (CD4.CD25 T Reg)
percentage of PBMC	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)
Flow Cytometric Analysis (CD4.CD25 T Reg)	-0.1 ± 4.3	1.4 ± 2.2	-0.1 ± 2.0

Statistical analysis

pp65-shLAMP DC With GM-CSF and Td (Arm 1) · Kruskal-Wallis · p = 0.13
pp65-flLAMP DC With GM-CSF and Td (Arm 2) · Kruskal-Wallis · p = 0.13
Unpulsed PBMC and Saline (Arm 3) · Kruskal-Wallis · p = 0.13

Adverse events

Collected over AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
pp65-shLAMP DC With GM-CSF and Td (Arm 1)	28/36 (77.8%)	8/36 (22.2%)	16/36 (44.4%)
pp65-flLAMP DC With GM-CSF and Td (Arm 2)	31/34 (91.2%)	6/34 (17.6%)	11/34 (32.4%)
Unpulsed PBMC and Saline (Arm 3)	31/41 (75.6%)	5/41 (12.2%)	13/41 (31.7%)

Most frequent serious events

Showing 10 of 14

Most frequent serious events
Event	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)
SeizureNervous system disorders	4/36	1/34	0/41
Neurology - Other (Specify, cerebral edema)Nervous system disorders	3/36	2/34	1/41
InfectionInfections and infestations	2/36	1/34	1/41
Gastrointestinal - Other (Specify, appendicitis)Gastrointestinal disorders	0/36	1/34	0/41
HematomaBlood and lymphatic system disorders	0/36	1/34	0/41
Syncope (fainting)Nervous system disorders	0/36	1/34	0/41
Thrombosis/thrombus/embolismVascular disorders	0/36	1/34	0/41
Sodium, serum-low (hyponatremia)Metabolism and nutrition disorders	1/36	0/34	0/41
Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sidedMusculoskeletal and connective tissue disorders	1/36	0/34	0/41
HydrocephalusNervous system disorders	1/36	0/34	0/41

Most frequent other events

Showing 10 of 29

Most frequent other events
Event	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)
LymphopeniaBlood and lymphatic system disorders	4/36	6/34	5/41
SeizureNervous system disorders	5/36	3/34	1/41
Neurology - OtherNervous system disorders	4/36	2/34	3/41
HypertensionCardiac disorders	2/36	0/34	4/41
PlateletsBlood and lymphatic system disorders	1/36	2/34	2/41
DiarrheaGastrointestinal disorders	2/36	0/34	0/41
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)General disorders	0/36	1/34	0/41
Gastrointestinal - OtherGastrointestinal disorders	0/36	1/34	0/41
HematomaBlood and lymphatic system disorders	0/36	1/34	0/41
Opportunistic infection associated with >=Grade 2 LymphopeniaInfections and infestations	1/36	1/34	0/41

Baseline characteristics

All subjects who received at least one DC vaccine were included in the modified intent to treat analysis.

Age, Continuous
Age, Continuous(years)	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)	Total
Median	61.0 (32.0 to 75.0)	56.0 (21.0 to 79.0)	59.0 (27.0 to 80.0)	58.0 (21.0 to 80.0)

Sex: Female, Male
Sex: Female, Male(Participants)	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)	Total
Female	8	9	13	30
Male	28	25	28	81

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)	Total
Hispanic or Latino	0	0	3	3
Not Hispanic or Latino	34	34	35	103
Unknown or Not Reported	2	0	3	5

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)	Total
American Indian or Alaska Native	0	0	0	0
Asian	1	2	1	4
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	2	0	2	4
White	32	32	36	100
More than one race	0	0	0	0
Unknown or Not Reported	1	0	2	3

Region of Enrollment
Region of Enrollment(participants)	pp65-shLAMP DC With GM-CSF and Td (Arm 1)	pp65-flLAMP DC With GM-CSF and Td (Arm 2)	Unpulsed PBMC and Saline (Arm 3)	Total
United States	36	34	41	111

Study locations

3 sites

University of Florida
Gainesville, Florida 32610, United States
Orlando Health
Orlando, Florida 32806, United States
Duke University Medical Center
Durham, North Carolina 27710, United States

References and documents

Study documents

Protocol and statistical analysis plan · Oct 7, 2024
Informed consent form · Oct 21, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02465268
Lead sponsor: University of Florida
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jun 8, 2015
Start date: Aug 9, 2016
Primary completion: Nov 30, 2023
Completion: Nov 30, 2023
Results posted: Jan 14, 2025
Last update: Jan 14, 2025

Study contacts

Duane Mitchell, MD, PhD

study chair · University of Florida

Maryam Rahman, MD

principal investigator · University of Florida

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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