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Virus Therapy

D2C7-IT + 2141-V11 for Brain Cancer

Phase 1

Waitlist Available

Led By Annick Desjardins, MD

Research Sponsored by Darell Bigner

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years old at the time of entry into the study

Histopathologically confirmed WHO grade 4 IDHwt GBM

Must not have

Patients with worsening steroid myopathy

Females who are pregnant or breast-feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new treatment for patients with recurrent glioblastoma. The treatment involves injecting a combination of D2C7-IT and 2141-V11 directly into the tumor

Who is the study for?

This trial is for adults over 18 with a specific brain cancer called WHO grade 4 IDHwt GBM. They must have had surgery recently, be able to undergo MRI scans, and not be pregnant or breastfeeding. Participants need normal blood counts and organ function tests, agree to use birth control, and can't have certain medical conditions or recent treatments with other cancer therapies.

What is being tested?

The study tests D2C7-IT combined with 2141-V11 in patients who've had brain surgery for recurrent glioblastoma. The treatment involves direct infusion into the brain followed by injections near lymph nodes over several weeks to see if it's safe and effective against the tumor.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions from immunotherapy such as flu-like symptoms, fatigue, allergic reactions, or complications from direct brain infusion like bleeding or infection.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My brain tumor is a confirmed grade 4 and not IDH mutant.

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I am mostly able to care for myself.

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My kidney function tests are within normal limits.

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I had surgery to remove a tumor 3-5 weeks ago as my doctor recommended.

Exclusion Criteria

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

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My muscle weakness is getting worse due to steroid use.

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I am not pregnant or breastfeeding.

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I am at risk of a severe brain condition due to pressure increase.

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I do not have an active infection, immunosuppressive disease, or HIV.

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I do not have any severe or unstable health conditions.

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I haven't had chemotherapy or bevacizumab in the last 4 weeks.

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I finished radiation therapy less than 12 weeks ago.

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I have not finished all recommended treatments for my condition.

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My tumor has a specific MGMT promoter status.

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I have active cancer in my brain.

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I have taken more than 4 mg of dexamethasone daily in the last 2 weeks.

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I am currently being treated for another cancer that is not related to my current diagnosis.

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I have not taken immune system medications for my autoimmune disease in the last 3 months.

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I cannot have an MRI due to my weight or metal implants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

- Efficacy

- Safety

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: D2C7-IT + 2141-V11Experimental Treatment2 Interventions

Single D2C7-IT intratumoral infusion (4613.2 ng/mL in 36 mL) over 72 hours followed by an 2141-V11 infusion over 7 hours. This is followed by injections of 2141-V11 (2mg) in the cervical perilymphatic (CPLI) subcutaneous area ipsilateral to the tumor at weeks 2, 4, 7, 10 and then every 3 weeks until week 49. After week 49 (equivalent of 1 year of every 3 weeks CPLI of 2141-V11), patients who have completed 1 year of CPL subcutaneous injections of 2141-V11 at 2 mg every 3 weeks, who benefit from the therapy, and desire to continue on therapy, will receive CPLI of 2141-V11 at 2 mg every 4-6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

D2C7-IT

2015

Completed Phase 1

~90

0 / 19Eligibility criteria met