What side effects are associated with this type of intervention?

The most common treatments for glioblastoma, such as temozolomide and immunotherapy, have notable side effects. Temozolomide often causes nausea, vomiting, fatigue, constipation, and myelosuppression. Immunotherapy can lead to immune-related adverse effects including skin rashes, colitis, hepatitis, thyroid dysfunction, and pneumonitis. Combining these treatments, as in the SurVaxM trial, may result in a combination of these side effects, requiring careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including temozolomide, which is often used in combination with radiation therapy. Bevacizumab, an anti-angiogenic drug, has also been approved for recurrent Glioblastoma. While SurVaxM is a cancer vaccine targeting survivin, there are no FDA-approved cancer vaccines specifically for Glioblastoma as of now. However, the concept of using immunotherapy, such as checkpoint inhibitors, is being actively explored in clinical trials.

What other types of research exist?

Promising alternatives to SurVaxM for Glioblastoma patients include: 1) Temozolomide plus Tumor Treating Fields (TTFields), which uses electric fields to disrupt cancer cell division; 2) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1; 3) Bevacizumab, an anti-VEGF antibody used to manage symptomatic edema; and 4) CAR T-cell therapy targeting specific glioblastoma antigens. These treatments have shown potential in clinical trials and may offer new hope for glioblastoma patients.

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Cancer Vaccine

SurVaxM + Temozolomide for Glioblastoma (SURVIVE Trial)

Phase 2

Waitlist Available

Led By Robert Fenstermaker, MD

Research Sponsored by MimiVax, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status ≥ 70

No evidence of progressive disease at post-chemoradiation timepoint

Must not have

Repeat craniotomy for tumor therapy after chemoradiation

Known HIV positivity or AIDS related illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Summary

This trial is testing if adding SurVaxM to standard chemotherapy helps patients with newly diagnosed glioblastoma live longer. SurVaxM works by boosting the immune system to fight cancer more effectively. SurVaxM is a vaccine developed for patients with malignant gliomas.

Who is the study for?

This trial is for adults over 18 with newly diagnosed glioblastoma of the cerebrum, who've completed initial radiation and chemotherapy without disease progression. They must be able to care for themselves mostly, have certain lab values within normal ranges, agree to contraception if applicable, and not be on high doses of steroids.

What is being tested?

The SURVIVE study tests whether adding a new drug called SurVaxM to standard temozolomide chemotherapy improves survival in patients with newly diagnosed glioblastoma compared to temozolomide alone. The effects on immune response against cancer cells are also studied.

What are the potential side effects?

Potential side effects include typical reactions from immunotherapy such as flu-like symptoms, fatigue, skin reactions at injection sites, and possible autoimmune responses. Temozolomide can cause nausea, hair loss, blood disorders like low platelet counts or anemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself but may not be able to do active work.

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My cancer did not worsen after my last treatment.

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I am 18 years old or older.

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I do not have any ongoing bleeding or conditions that increase my risk of bleeding.

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I have been diagnosed with glioblastoma in my brain.

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I completed radiation therapy with TMZ following the Stupp protocol.

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I am taking 4 mg or less of dexamethasone daily.

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My tumor has been tested for the IDH-1 mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a second brain surgery for my tumor after undergoing chemotherapy and radiation.

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I am HIV positive or have an AIDS-related illness.

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I cannot have MRI scans or use gadolinium contrast.

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I have had carmustine wafers surgically implanted.

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I do not have a serious illness or infection that could interfere with treatment.

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My brain cancer has come back or gotten worse.

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I have had tuberculosis or a similar disease in the past.

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I have been treated with bevacizumab.

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I have had cancer before, but it was successfully treated.

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I received a unique radiation treatment for my brain cancer.

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I cannot take temozolomide due to health reasons.

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My cancer is not glioblastoma.

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I have been treated with chemotherapy or experimental drugs before.

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My brain cancer affects multiple areas or specific parts of my brain.

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I have received immunotherapy for my brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Grade 3 & Grade 4 Toxicities

Overall Survival at Specified Time Points

Progression Free Survival Comparison

+1 more

Other study objectives

Evaluate molecular predictors of response to SurVaxM

Objective Image Based Tumor Response Rate

Predictive Value of perfusion-weighted imaging - pseudo-progression

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Arm AActive Control1 Intervention

Peptide Vaccine (SurVaxM) in emulsion with Montanide given together with locally administered Sargramostim plus adjuvant oral Temozolomide

Group II: Arm BPlacebo Group1 Intervention

Saline-Montanide emulsion with locally administered saline (instead of sargramostim) plus adjuvant oral temozolomide

0 / 23Eligibility criteria met

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

Glioblastoma treatments often involve a combination of surgery, radiation therapy, and chemotherapy with temozolomide. Temozolomide works by damaging the DNA of cancer cells, making it difficult for them to replicate. Radiation therapy uses high-energy rays to kill cancer cells and shrink tumors. Immunotherapy, such as the SurVaxM vaccine, stimulates the immune system to target survivin, a protein commonly overexpressed in Glioblastoma cells, thereby enhancing the body's ability to fight the cancer. These treatments are crucial for Glioblastoma patients as they target the tumor through multiple mechanisms, potentially improving survival rates and quality of life.