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Cancer Vaccine

DC vaccination with Td preconditioning and GM CSF for Glioblastoma (I-ATTAC Trial)

Phase 2
Waitlist Available
Research Sponsored by Gary Archer Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Median Overall Survival (OS) of Subjects Receiving Td Pre-conditioning With GM-CSF
Secondary study objectives
Chemokine (C-C Motif) Ligand 3 (CCL3) and Survival From Vaccine 4
Maximum Peak Increase From Vaccine 1 in Percent Regulatory T Cells (TReg) of CD4+ T Cells
Migration and Survival From Vaccine 4
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: DC vaccination with Td preconditioning and GM CSFExperimental Treatment5 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
FDA approved
Sargramostim
FDA approved
Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated)
FDA approved

Find a Location

Who is running the clinical trial?

Gary Archer Ph.D.Lead Sponsor
11 Previous Clinical Trials
286 Total Patients Enrolled
9 Trials studying Glioblastoma
232 Patients Enrolled for Glioblastoma
Mustafa Khasraw, MBChB, MD, FRCP, FRACPLead Sponsor
3 Previous Clinical Trials
115 Total Patients Enrolled
1 Trials studying Glioblastoma
64 Patients Enrolled for Glioblastoma
~1 spots leftby Sep 2025
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