What side effects are associated with this type of intervention?

Common treatments for glioblastoma, particularly immunotherapy, include checkpoint inhibitors and targeted therapies. Known side effects of these treatments can include cutaneous immune-related adverse events such as rash and pruritus, as well as more severe reactions like colitis, hepatitis, and endocrinopathies. Additionally, patients may experience fatigue, headache, and infusion-related reactions. These side effects vary in severity and frequency, and management often requires a multidisciplinary approach.

What prior FDA approvals exist?

The FDA has approved several treatments for glioblastoma, including temozolomide, which is often used in combination with radiotherapy. Immunotherapy options, such as pembrolizumab, have shown promise in early-phase clinical trials for various cancers, including glioblastoma. The trial ITI-1001 is exploring a novel immunotherapy approach, which aligns with the growing interest in targeting glioblastoma through immune system modulation. While specific FDA approvals for immunotherapy targeting glioblastoma are limited, ongoing research and trials like ITI-1001 are paving the way for potential new treatments.

What other types of research exist?

Promising alternatives to ITI-1001 for glioblastoma treatment in 2024 include: 1) Bevacizumab, an anti-angiogenic therapy, which has shown efficacy in various trials. 2) Nivolumab, a PD-1 inhibitor, which has been evaluated in combination with other therapies. 3) Everolimus, an mTOR inhibitor, which has been studied for its potential to inhibit tumor growth. 4) Combination therapies involving checkpoint inhibitors like pembrolizumab with other agents. These alternatives have shown potential in clinical trials and may offer new hope for glioblastoma patients.

← Back to Search

Virus Therapy

ITI-1001 for Glioblastoma

Phase 1

Waitlist Available

Research Sponsored by Immunomic Therapeutics, Inc.

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 through study completion, up to 2 years post baseline.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new vaccine for brain cancer. It targets patients with newly diagnosed glioblastoma. The vaccine aims to help the immune system fight the cancer. The treatment has been shown to be safe and feasible in previous studies.

Who is the study for?

Adults over 18 with newly diagnosed glioblastoma who've had most of their tumor surgically removed and are set for standard chemoradiation. They should expect to live at least 3 more months, have good organ function, agree to use contraception, and not be in other clinical trials or have certain health conditions that could interfere with the study.

What is being tested?

The trial is testing ITI-1001 at a dose of 8 mg to see if it's safe and tolerable for patients with new glioblastoma. It also looks at how the body responds to the drug (immunogenicity) and whether it seems effective against this type of brain cancer.

What are the potential side effects?

Specific side effects aren't listed here, but generally, participants will be monitored for any adverse reactions related to ITI-1001 which can range from mild injection site reactions to more serious immune responses or organ-related issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 2 years post baseline.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 2 years post baseline.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2 years post baseline. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of occurrences of Adverse events/Serious Adverse Events that will be assessed for severity according to the NCI CTCAE, version 5.0.

Number of participants with Dose Limiting Toxicities (DLTs).

Other study objectives

Exploratory endpoints include changes in immune response

Exploratory endpoints include changes in peripheral blood assessment of T cell activation

Exploratory endpoints include evaluation preliminary efficacy; Neurological Assessment in Neuro-oncology (NANO) analysis

+2 more

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: Participants with Newly Diagnosed Glioblastoma (GBM)Experimental Treatment1 Intervention

Ten participants with histopathological diagnosis of WHO grade IV glioma (Glioblastoma; GBM) and have undergone a gross/near gross total surgical resection of tumor by analysis of residual enhancing tumor remnant on the immediate post-operative MRI

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

Glioblastoma treatments primarily include chemotherapy, radiotherapy, and immunotherapy. Chemotherapy, such as temozolomide, works by damaging the DNA of cancer cells, leading to cell death. Radiotherapy uses high-energy radiation to kill cancer cells and shrink tumors. Immunotherapy, including treatments like ITI-1001, aims to harness the body's immune system to recognize and attack glioblastoma cells. This is particularly important for glioblastoma patients because the tumor's aggressive nature and ability to evade the immune system make it challenging to treat. Immunotherapy offers a promising approach by potentially providing a more targeted and sustained response against the tumor.