CD200AR-L + Vaccine for Brain Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination for brain tumors in children and young adults. The main goal is to determine the safest dose of CD200AR-L, an experimental drug, when used with a vaccine and other treatments to combat aggressive brain tumors like High Grade Glioma and certain newly diagnosed tumors post-radiation. It targets individuals with recurrent High Grade Glioma or specific newly diagnosed brain tumors who have completed some standard treatments. Participants must be able to attend follow-up visits and maintain a stable health condition with controlled symptoms. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) of at least 28 days since the last dose of any targeted therapy, immunotherapy, or investigational agents, and at least 10 days since any anti-cancer intervention. If you are on these types of treatments, you will need to stop them before joining the trial.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that CD200AR-L remains in the early testing stages to ensure safety. The primary goal is to determine the safe dosage for patients. As this is an early phase trial, limited data from human participants exists. Therefore, researchers are carefully testing the treatment to assess tolerance and identify any potential side effects.
Before human testing, scientists conducted preclinical studies and found that CD200AR-L might enhance the immune system's ability to fight tumors. However, these studies do not always predict how a treatment will perform in humans. This trial is crucial for gathering real safety data in humans.
Prospective participants should know that researchers are still closely monitoring and studying the treatment's safety.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for brain tumors, which typically involve surgery, radiation, and chemotherapy, CD200AR-L offers a novel approach. It works by using a combination of a targeted peptide and a vaccine to potentially enhance the immune system's response against tumor cells. Researchers are excited because this method could improve how the body identifies and attacks cancer, possibly leading to better outcomes with fewer side effects. Additionally, the treatment includes a strategic re-irradiation step and uses topical imiquimod to further stimulate immune activity, which is a fresh, multi-faceted approach not commonly seen in current therapies.
What evidence suggests that CD200AR-L + Vaccine might be an effective treatment for brain tumors?
In this trial, participants will receive a combination of CD200AR-L with the GBM6-AD vaccine and imiquimod, which may offer a promising treatment for aggressive brain tumors in children and young adults. CD200AR-L enhances the immune system's ability to fight the tumor. Early studies with similar treatments have shown they can slow tumor growth. The GBM6-AD vaccine aids the immune system in recognizing and attacking the tumor by targeting specific markers on the tumor cells. Imiquimod, a cream, boosts the immune response at the tumor site. Together, these treatments aim to strengthen the body's natural defenses against cancer.12346
Are You a Good Fit for This Trial?
This trial is for children and young adults with malignant glioma, specifically those with recurrent High Grade Glioma (HGG) or newly diagnosed Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma (DIPG/DMG). Participants must have completed standard radiation therapy if they are newly diagnosed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CD200AR-L, GBM6-AD vaccine, and imiquimod, with a single dose of radiation on day 15. Treatment includes weekly injections for the first 3 weeks, then every 4 weeks starting at week 7 for 8 weeks, and every 8 weeks starting at week 19 for 2 years.
Radiation
A single dose of 300 cGy radiation is administered on day 15 to sensitize the tumor to immune attack.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including MRIs, blood work, and performance assessments.
Open-label extension (optional)
Participants may opt into continuation of treatment beyond 2 years if they are tolerating the treatment and their tumor is controlled.
What Are the Treatments Tested in This Trial?
Interventions
- CD200AR-L
Find a Clinic Near You
Who Is Running the Clinical Trial?
OX2 Therapeutics
Lead Sponsor