What side effects are associated with this type of intervention?

The most common treatments for glioblastoma include the Survivin Peptide Vaccine, which aims to stimulate the immune response, and Temozolomide, a chemotherapy drug. The Survivin Peptide Vaccine can cause side effects such as injection site reactions, fever, and fatigue. Temozolomide is associated with side effects including nausea, vomiting, fatigue, constipation, and myelosuppression (a decrease in bone marrow activity leading to fewer blood cells). Both treatments aim to target and reduce tumor growth but come with their respective side effect profiles.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, with Temozolomide being a cornerstone chemotherapy agent. Temozolomide works by stopping the growth of tumor cells and is often used in combination with radiation therapy. Additionally, immune response stimulation therapies, such as the use of vaccines targeting tumor-specific antigens, are under investigation. While the Survivin Peptide Vaccine is still in clinical trials, it represents a promising approach to harness the body's immune system to target and kill tumor cells. These treatments aim to improve survival and quality of life for patients with Glioblastoma.

What other types of research exist?

Promising novel alternatives for Glioblastoma treatment in 2024 include: 1) CAR T-cell therapy, which involves modifying a patient's T-cells to target glioblastoma cells. 2) Oncolytic virus therapy, such as DNX-2401, which uses viruses to selectively infect and kill tumor cells. 3) Tumor Treating Fields (TTF), a non-invasive treatment that uses electric fields to disrupt cancer cell division. 4) New checkpoint inhibitors targeting PD-1/PD-L1 pathways, potentially in combination with other therapies. 5) Personalized vaccine approaches, such as neoantigen vaccines, which are tailored to the unique mutations in a patient's tumor.

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Cancer Vaccine

Vaccine Therapy + Temozolomide for Glioblastoma

Phase 2

Waitlist Available

Led By Robert Fenstermaker

Research Sponsored by Roswell Park Cancer Institute

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 date of diagnosis until (1) date of death or (2) the last date patient known alive (if death is not observed), assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well a special vaccine works with a common chemotherapy drug in treating patients with recently found brain cancer. The vaccine helps the immune system fight the cancer, while the chemotherapy attacks the cancer cells directly.

Who is the study for?

This trial is for patients with newly diagnosed glioblastoma who've had surgery and chemotherapy with temozolomide, without disease progression. They must have a specific immune system type (HLA-A*02, A*03, A*11 or A*24), good kidney function, no serious bleeding risks or infections, not be pregnant or breastfeeding, and agree to use contraception.

What is being tested?

The study tests if adding a survivin peptide vaccine (SurVaxM) to the standard treatment of temozolomide improves outcomes in glioblastoma patients. The vaccine aims to help the body's immune system attack tumor cells that express survivin—a protein found in cancer cells.

What are the potential side effects?

Possible side effects include reactions at the injection site from the vaccine therapy, flu-like symptoms such as fever and chills, fatigue from temozolomide chemotherapy, and potential blood-related issues like low platelet counts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of diagnosis until (1) date of death or (2) the last date patient known alive (if death is not observed), assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of diagnosis until (1) date of death or (2) the last date patient known alive (if death is not observed), assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of diagnosis until (1) date of death or (2) the last date patient known alive (if death is not observed), assessed up to 2 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

Progression-free Survival (PFS)

Secondary study objectives

Immune Responses to SurVaxM and Predictors of Response

Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4

Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (SurVaxM, temozolomide)Experimental Treatment5 Interventions

Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Montanide ISA 51 VG

2008

Completed Phase 3

~610

Sargramostim

2006

Completed Phase 4

~850

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Survivin Peptide Vaccine works by stimulating the immune system to recognize and attack tumor cells that express the survivin protein, which is commonly found in Glioblastoma cells. This immune response aims to reduce tumor growth and improve patient outcomes. Temozolomide, a chemotherapy agent, works by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate and leading to cell death. This is particularly important for Glioblastoma patients as the aggressive nature of the tumor requires treatments that can effectively target and kill rapidly dividing cells. Together, these treatments offer a dual approach: enhancing the body's immune response while directly targeting tumor cell replication.