What side effects are associated with this type of intervention?

Common side effects of immune system activation therapies for Ependymoma, similar to SurVaxM, include injection site reactions, flu-like symptoms (fever, chills, fatigue), gastrointestinal issues (nausea, diarrhea), and immune-related adverse events such as skin rashes, thyroid dysfunction, and more severe autoimmune reactions affecting organs like the liver, lungs, or colon.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for ependymoma that involve immune system activation targeting survivin-expressing tumor cells in the provided context. However, SurVaxM is an investigational vaccine designed to stimulate the immune system to target and destroy tumor cells expressing the survivin protein, which is found in various cancers. This approach represents a novel therapeutic strategy, and ongoing clinical trials are evaluating its efficacy and safety in treating ependymoma and other cancers.

What other types of research exist?

Promising novel alternatives to SurVaxM for Ependymoma patients include: 1) Immune checkpoint inhibitors such as nivolumab or pembrolizumab, which enhance the immune system's ability to target cancer cells. 2) ONC201, an investigational oral compound targeting H3 K27M-mutant gliomas, which may have potential applications in Ependymoma. 3) Chimeric Antigen Receptor (CAR) T-cell therapies targeting specific tumor antigens. 4) DNX-2401, an oncolytic adenovirus being studied for its ability to selectively infect and kill tumor cells. These therapies are in various stages of clinical development and may offer new hope for Ependymoma patients.

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Cancer Vaccine

SurVaxM Vaccine for Brain Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for Ependymoma include surgery, radiation therapy, and chemotherapy. Recently, immunotherapy approaches like SurVaxM have gained attention. SurVaxM activates the immune system to target and destroy tumor cells expressing the survivin protein, which is prevalent in many cancers but not in normal cells. This targeted approach is crucial for Ependymoma patients as it aims to reduce tumor growth and recurrence with potentially fewer side effects compared to traditional therapies. By harnessing the body's immune system, these treatments offer a promising avenue for more effective and personalized cancer care.

Phase 1

Recruiting

Research Sponsored by Pediatric Brain Tumor Consortium

Eligibility Criteria Checklist

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

Must have

For patients with known evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Patients with newly diagnosed diffuse intrinsic pontine gliomas (DIPGs), defined as tumors with a pontine epicenter and diffuse involvement of 2/3 or more of the pons, are eligible without histologic confirmation and will proceed directly to enrollment without screening

Must not have

History of any lymphoproliferative disorder

Active, uncontrolled infection requiring treatment (including HIV infection)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years from treatment initiation

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the SurVaxM vaccine, which helps the immune system target and destroy cancer cells, in children and young adults with certain difficult-to-treat brain cancers. The vaccine works by teaching the immune system to recognize a protein found in cancer cells. Additional substances are used to make the immune response stronger.

Who is the study for?

This trial is for children and young adults aged 1 to 21 with specific brain tumors (like medulloblastoma, high-grade glioma, ependymoma) that are progressive or relapsed. They must have completed prior treatments without severe side effects, be HIV-negative or well-controlled on therapy, and have good organ function. Participants need to agree to use birth control and provide consent.

What is being tested?

The study tests SurVaxM vaccine combined with Montanide ISA 51 in two phases: Priming (4 doses every 2 weeks) and Maintenance (doses every 8 weeks up to two years). It aims to train the immune system to attack tumor cells expressing survivin protein. Sargramostim is also given to boost the immune response.

What are the potential side effects?

Potential side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, muscle aches, possible allergic reactions due to KLH content in SurVaxM or sargramostim components. Long-term follow-up will monitor for any delayed side effects.

Eligibility Criteria

Inclusion Criteria

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

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My hepatitis B virus load is undetectable with treatment.

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I have a newly diagnosed brain tumor in the pons without needing a biopsy.

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My cancer can be measured or seen on tests.

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My tumor shows at least 1% survivin expression, confirmed by a test at RPCCC.

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I received my last cancer treatment affecting bone marrow over 21 days ago, or over 42 days ago if it was a specific type.

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I am HIV positive, on effective treatment, and my viral load has been undetectable for 6 months.

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I finished my radiation for DIPG between 2 to 8 weeks ago and my cancer hasn't worsened.

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I am between 1 and 21 years old.

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I have recovered from side effects of my last antibody treatment, taken over 28 days ago.

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I do not have a bleeding disorder nor am I on blood thinners.

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I finished my radiation therapy between 2 to 8 weeks ago and haven't had other cancer treatments since.

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My brain tumor is growing or has returned after standard treatment.

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My brain tumor is confirmed as GBM or Grade II/III astrocytoma.

Exclusion Criteria

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

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I have had a condition where my lymphocytes grow abnormally.

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I do not have an active infection needing treatment.

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I am willing and able to follow the study's required visits, tests, and treatment plan.

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I have or had lung inflammation or significant lung disease.

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I am currently using CBD or medical marijuana.

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My brain tumor is not in the pons or brainstem and is classified as Grade I or II.

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I have a history of cancer.

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My brain tumor has returned or gotten worse.

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I am not currently on any cancer treatment or experimental drugs.

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I have an active autoimmune disease or a history of one that needs ongoing treatment.

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I have been diagnosed with Grade I myxopapillary ependymoma.

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I am currently on immunosuppressive therapy, including corticosteroids.

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My cancer originated in my spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years from treatment initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years from treatment initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from treatment initiation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Subjects with Pseudoprogression Related Regimen-Limiting Toxicity

Percentage of Subjects with Regimen-Limiting Toxicity (RLT)

Secondary study objectives

Differences in MR permeability and MR perfusion parameters for patients with true progression vs. pseudoprogression

Other study objectives

Best Response Rate

Overall Survival

Progression Free Survival

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥10 and ≤21 yearsExperimental Treatment1 Intervention

500 mcg (1 mL) SurVaxM emulsion with Montanide ISA 51. Sargramostim dose is 3.33 mcg/kg/dose for patients \< 30 kg, and 100 mcg for patients ≥ 30 kg. Priming Phase: patients will get one dose of SurVaxM combined with Montanide ISA 51 through a subcutaneous injection at the start of the study and every 2 weeks for 6 weeks (for a total of 4 doses). At each SurVaxM/Montanide ISA 51 injection, patients will also get an injection of sargramostim. Maintenance Phase: the patient will get a SurVaxM/Montanide ISA 51 dose along with a sargramostim dose about every 8 weeks for up to two years. After finishing study treatment, patients will be followed for up to 3 years following the last dose of SurVaxM/Montanide ISA 51. Patients will be followed in clinic every 3 months during the follow-up.

Group II: SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥1 and <10 yearsExperimental Treatment1 Intervention

Group III: SurVaxM for patients with non-relapsed DIPG post radiation-therapy ages ≥1 and ≤21 yearsExperimental Treatment1 Intervention

0 / 26Eligibility 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

The most common treatments for Ependymoma include surgery, radiation therapy, and chemotherapy. Recently, immunotherapy approaches like SurVaxM have gained attention. SurVaxM activates the immune system to target and destroy tumor cells expressing the survivin protein, which is prevalent in many cancers but not in normal cells. This targeted approach is crucial for Ependymoma patients as it aims to reduce tumor growth and recurrence with potentially fewer side effects compared to traditional therapies. By harnessing the body's immune system, these treatments offer a promising avenue for more effective and personalized cancer care.

Treatment of adult brainstem glioma with combined antiangiogenic therapy: a case report and literature review.