Anti-CMV Dendritic Cell Vaccine - Revision history

Lazy at 08:28, 18 January 2025

2025-01-18T08:28:12Z

← Older revision		Revision as of 01:28, 18 January 2025
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	}}		\|overview=The Anti-CMV Dendritic Cell Vaccine is a promising Phase II clinical trial treatment for newly diagnosed and recurrent Glioblastoma Multiforme (GBM) that targets cytomegalovirus antigens in tumor cells, showing potential median overall survival rates significantly higher than historical controls. While currently not FDA-approved, early trial results indicate extended survival and favorable safety profiles compared to standard treatments.}}

Lazy at 13:46, 25 December 2024

2024-12-25T13:46:06Z

← Older revision		Revision as of 06:46, 25 December 2024
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	ATTAC-II trial at the University of Florida (NCT02465268), and the AVERT trial for		ATTAC-II trial at the University of Florida (NCT02465268), and the AVERT trial for
	recurrent grade III glioma and GBM at Duke University (NCT02529072).		recurrent grade III glioma and GBM at Duke University (NCT02529072).
	~~\|treatment_category=Tumor-associated antigen vaccines~~

	}}		}}

Lazy at 13:45, 25 December 2024

2024-12-25T13:45:01Z

← Older revision		Revision as of 06:45, 25 December 2024
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	\|OS_without=Historical controls indicate median overall survival around 15-17 months for newly diagnosed GBM.		\|OS_without=Historical controls indicate median overall survival around 15-17 months for newly diagnosed GBM.
	\|OS_with=Varied; one study showed median OS of 41.1 months with vaccine and temozolomide, and another indicated 30.3 months with vaccine and basiliximod.		\|OS_with=Varied; one study showed median OS of 41.1 months with vaccine and temozolomide, and another indicated 30.3 months with vaccine and basiliximod.
			\|treatment_category=Vaccines
	\|PFS_without=Typically around 6-7 months for standard GBM treatments.		\|PFS_without=Typically around 6-7 months for standard GBM treatments.
	\|PFS_with=Impressive 25.3 months in a study combining vaccine with dose-intense temozolomide.		\|PFS_with=Impressive 25.3 months in a study combining vaccine with dose-intense temozolomide.

69.163.248.232: Updated category= to treatment_category= in TreatmentInfo template

2024-11-12T18:45:02Z

Updated category= to treatment_category= in TreatmentInfo template

← Older revision		Revision as of 11:45, 12 November 2024
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	ATTAC-II trial at the University of Florida (NCT02465268), and the AVERT trial for		ATTAC-II trial at the University of Florida (NCT02465268), and the AVERT trial for
	recurrent grade III glioma and GBM at Duke University (NCT02529072).		recurrent grade III glioma and GBM at Duke University (NCT02529072).
	\|~~category~~=Tumor-associated antigen vaccines		\|treatment_category=Tumor-associated antigen vaccines

	}}		}}

Lazy at 21:31, 31 March 2024

2024-03-31T21:31:39Z

← Older revision		Revision as of 14:31, 31 March 2024
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	ATTAC-II trial at the University of Florida (NCT02465268), and the AVERT trial for		ATTAC-II trial at the University of Florida (NCT02465268), and the AVERT trial for
	recurrent grade III glioma and GBM at Duke University (NCT02529072).		recurrent grade III glioma and GBM at Duke University (NCT02529072).
			\|category=Tumor-associated antigen vaccines

	}}		}}

Lazy: Created page with "{{TreatmentInfo |drug_name=Anti-CMV Dendritic Cell Vaccine |FDA_approval=In clinical trials; not yet FDA-approved |used_for=Newly diagnosed and recurrent Glioblastoma Multiforme (GBM) |clinical_trial_phase=Phase II |common_side_effects=Not detailed; dendritic cell vaccines are generally well-tolerated with mild side effects. |OS_without=Historical controls indicate median overall survival around 15-17 months for newly diagnosed GBM. |OS_with=Varied; one study showed medi..."

2024-03-31T21:19:23Z

Created page with "{{TreatmentInfo |drug_name=Anti-CMV Dendritic Cell Vaccine |FDA_approval=In clinical trials; not yet FDA-approved |used_for=Newly diagnosed and recurrent Glioblastoma Multiforme (GBM) |clinical_trial_phase=Phase II |common_side_effects=Not detailed; dendritic cell vaccines are generally well-tolerated with mild side effects. |OS_without=Historical controls indicate median overall survival around 15-17 months for newly diagnosed GBM. |OS_with=Varied; one study showed medi..."

New page

{{TreatmentInfo
|drug_name=Anti-CMV Dendritic Cell Vaccine
|FDA_approval=In clinical trials; not yet FDA-approved
|used_for=Newly diagnosed and recurrent Glioblastoma Multiforme (GBM)
|clinical_trial_phase=Phase II
|common_side_effects=Not detailed; dendritic cell vaccines are generally well-tolerated with mild side effects.
|OS_without=Historical controls indicate median overall survival around 15-17 months for newly diagnosed GBM.
|OS_with=Varied; one study showed median OS of 41.1 months with vaccine and temozolomide, and another indicated 30.3 months with vaccine and basiliximod.
|PFS_without=Typically around 6-7 months for standard GBM treatments.
|PFS_with=Impressive 25.3 months in a study combining vaccine with dose-intense temozolomide.
|usefulness_rating=4
|usefulness_explanation=This vaccine represents a promising strategy by targeting CMV antigens present in GBM cells, potentially extending survival significantly beyond standard treatments. Initial results suggest substantial benefits for certain patient groups.
|toxicity_level=2
|toxicity_explanation=Dendritic cell vaccines like this one are known for their favorable safety profile, with predominantly mild, manageable adverse effects.
|book_text=This approach relies on the finding that most GBM tumors are infected with the
cytomegalovirus, a common herpes virus. GBMs have a high incidence of the virus being
present (by some estimates over 90%) whereas normal brain cells do not. The new
treatment approach involves targeting a specific protein component of the CMV virus,
which then kills the virus and the cell harboring it.

Results of a small trial for Duke’s anti-CMV dendritic cell vaccine with or without
preconditioning with an injection of tetanus/diptheria toxoid was published in Nature in
March 2015 (320). There were 6 newly diagnosed glioblastoma patients in each arm. In
the 6 patients treated with the vaccine but without tetanus/diptheria preconditioning,
median progression-free and overall survival freom diagnosis was 10.8 and 18.5, not
significantly better than historical controls. In the group of patients receiving
preconditioning of the injection site with tetanus/diptheria, three of the patients were
alive without disease progression at 44-47 months from diagnosis. A Wall Street Journal
article published at the same time as the Nature study gave more up-to-date information,
revealing that two of these longer-term survivors had died at nearly 5 and 6 years from
diagnosis, while the remaining patient was still alive over 8 years from diagnosis. An
update from the 2016 AANS conference revealed that this patient was still alive without
tumor regrowth at 120 months (10 years). The purpose of the tetanus/diptheria booster is
to improve migration of the dendritic cells to lymph nodes. Despite the striking success of
the anti-CMV dendritic cell vaccine combined with a tetanus/diptheria booster injection,
a randomized phase 2 trial is scheduled to open in 2015 with one arm randomized to
receive the tetanus/diptheria toxoid preconditioning, and the other arm randomized to

receive saline (essentially placebo). Both arms receive the anti-CMV dendritic cell vaccine
(trial NCT02366728).

A second single-arm phase II trial (ATTAC-GM) combined dose-intense temozolomide
(100 mg/mz2 for 21 days of a 28 day cycle) with anti-CMV dendritic cell vaccine and
tetanus preconditioning. Median progression-free and overall survival for the 11 patients
was a remarkable 25.3 and 41.1 months. This data was presented at the 2016 annual
AANS meeting by Kristen Batich.

A separate trial (NCT00626483) at Duke for newly diagnosed glioblastoma is testing the
CMV-targeted dendritic cell vaccine in combination with basiliximab, a CD25 antibody
intended to inhibit the regulatory T-cell (Treg) population. In an abstract published for
the ASCO 2015 meeting, we can read that in a pilot study of seven patients treated with
this combination therapy, median progression-free and overall survival was an impressive
23.5 and 30.3 months respectively.

Currently recruiting clinical trials testing CMV pp65 vaccines with or without
tetanus/diptheria preconditioning or basiliximab include the ELEVATE trial at Duke
University (NCT02366728), the PERFORMANCE trial also at Duke (NCT02864368), the
ATTAC-II trial at the University of Florida (NCT02465268), and the AVERT trial for
recurrent grade III glioma and GBM at Duke University (NCT02529072).
}}