What side effects are associated with this type of intervention?

Common treatments for glioblastoma include chemotherapy, radiation therapy, and targeted therapies. Chemotherapy, such as temozolomide, often causes side effects like nausea, fatigue, and myelosuppression (reduced bone marrow activity). Radiation therapy can lead to fatigue, hair loss, and skin changes. Targeted therapies, including those that inhibit specific molecular pathways, may cause side effects such as rash, diarrhea, and liver toxicity. For treatments similar to CD200 Activation Receptor Ligand (CD200AR-L), potential side effects could include immune-related reactions, as these therapies often modulate the immune system. Common immune-related side effects might include inflammation, fatigue, and flu-like symptoms.

What prior FDA approvals exist?

FDA-approved treatments for glioblastoma include temozolomide, a standard chemotherapeutic agent often used in combination with radiation therapy, and bevacizumab, an angiogenesis inhibitor targeting VEGF. While specific FDA approvals for CD200 Activation Receptor Ligand (hP1A8) are not mentioned, ongoing research in immunotherapy and novel agents like tirapazamine, a bioreductive agent, indicates a focus on innovative approaches to treat glioblastoma. These treatments aim to improve outcomes by targeting tumor growth and enhancing the immune response.

What other types of research exist?

Promising novel alternatives to hP1A8 for Glioblastoma patients include: 1) Bevacizumab, an anti-angiogenic therapy shown to be effective in various trials. 2) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, which has shown potential in treating glioblastoma. 3) Everolimus, an mTORC1 inhibitor, which has been studied for its efficacy in glioblastoma. 4) Combination therapies such as nivolumab with ipilimumab, which are being explored for their synergistic effects in enhancing immune response against tumors.

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Cancer Vaccine

hP1A8 Immunotherapy for Glioblastoma

Phase 1

Waitlist Available

Research Sponsored by OX2 Therapeutics

Eligibility Criteria Checklist

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

Must have

Confirmed diagnosis of GBM.

Radiographically or histologically proven progression or recurrence of disease at any time after standard of care therapy (radiation, temozolomide, with or without a tumor treatment field device).

Must not have

Intercurrent immune system disorder such as hypoimmunity (marrow failure, HIV) or hyperimmunity (autoimmune disease)

Unable to complete a standard upfront course of chemoradiotherapy due to disease progression or intolerance of therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of treatments to help the immune system fight recurrent brain cancer in adults. It includes a special protein, an immune-boosting cream, and a vaccine targeting cancer cells.

Who is the study for?

Adults diagnosed with recurrent glioblastoma (GBM) who have seen their disease progress or return after standard treatments like radiation and chemotherapy. They must not have used certain drugs like Bevacizumab recently, nor have immune disorders, intolerance to previous chemoradiotherapy, history of specific implanted agents, or be using tumor treatment field devices.

What is being tested?

The trial is testing hP1A8 combined with imiquimod and the GBM6-AD vaccine as a new treatment for GBM. It's an early-phase study to find the right dose range and it's open-label, meaning everyone knows what treatment they're getting.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions to immunotherapy such as flu-like symptoms, injection site reactions, fatigue, fever, chills and possible autoimmune responses due to CD200AR-L activation.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with glioblastoma (GBM).

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My cancer has worsened or returned after standard treatment.

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I have been diagnosed with glioblastoma multiforme (GBM).

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My cancer has worsened or returned after standard treatment.

Exclusion Criteria

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

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I have a condition affecting my immune system, like HIV or an autoimmune disease.

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I couldn't finish my initial cancer treatment because it was too harsh or my cancer got worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: hP1A8Experimental Treatment1 Intervention

Up to 3 dose levels of hP1A8 will be tested with a Dose Level -1 in the event of toxicity. The MTD will be identified using the standard 3+3 design. Upon determination of the MTD, additional patients will be enrolled as part of an expansion cohort.

0 / 6Eligibility 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

Common treatments for Glioblastoma include temozolomide, radiation therapy, and bevacizumab. Temozolomide is an oral chemotherapy drug that works by methylating DNA, leading to tumor cell death. Radiation therapy uses high-energy rays to damage the DNA of cancer cells, inhibiting their ability to reproduce. Bevacizumab is a monoclonal antibody that targets vascular endothelial growth factor (VEGF), reducing blood supply to the tumor and thereby inhibiting its growth. The trial hP1A8 involves a CD200 Activation Receptor Ligand, which aims to modulate the immune response against the tumor. These treatments are crucial for Glioblastoma patients as they target different aspects of tumor growth and survival, potentially improving outcomes and extending survival.