Personalized Vaccine + TTFields for Glioblastoma

Palo Alto (17 mi)

Overseen byAdilia Hormigo, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Albert Einstein College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to use precision medicine in the form of a vaccine, a mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields). The study is designed to determine whether this treatment combination is well tolerated and safe.

Eligibility Criteria

Adults over 18 with confirmed Glioblastoma (GBM) who have stable disease after radiation and chemotherapy, a life expectancy of more than 16 weeks, and good performance status. They must have completed maximal surgery, radiotherapy with Temozolomide, and be on a low dose of Dexamethasone. Participants need sufficient tumor tissue for sequencing and acceptable organ function. They should not have certain autoimmune diseases or implanted electronic devices in the brain.

Inclusion Criteria

I am 18 years old or older.

My diagnosis is Grade IV brain cancer (GBM).

I am undergoing surgery to remove as much of the tumor as possible, followed by radiation therapy with Temozolomide.

My bone marrow is functioning well.

My first vaccine dose is scheduled 4-8 weeks after my last Temozolomide or radiotherapy dose.

I can take care of myself and perform daily activities.

I am on a stable dose of Dexamethasone, 4mg or less daily.

Exclusion Criteria

I have HIV/AIDS or chronic hepatitis B/C.

My condition has worsened recently.

My cancer is located below the tentorium in my brain or is present in multiple areas.

I have a condition that weakens my immune system.

I had cancer before and was treated for it within the last year.

Treatment Details

The trial is testing the safety of a personalized genomic vaccine combined with TTFields against GBM. The vaccine targets mutations in each patient's tumor alongside standard treatments to see if it's safe and well-tolerated.

1Treatment groups

Experimental Treatment

Group I: Mutation-derived tumor vaccineExperimental Treatment3 Interventions

MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields