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Anti-metabolites

DB107-RRV + DB107-FC for Brain Tumors

Phase 2

Recruiting

Led By Ashish Shah, MD

Research Sponsored by Ashish Shah

Eligibility Criteria Checklist

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

Must have

Karnofsky Performance Score (KPS) ≥ 70

Patients aged 18-75 years old

Must not have

Intention to undergo treatment with Gliadel® wafer at the time of surgery or recent use of Gliadel® wafer

Gastrointestinal diseases that prevent absorption of medications such as 5-FC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial aims to see if a new combination treatment can reduce the size of a type of brain cancer called high-grade glioma in patients with recurrent or progressive disease, whether the tumor can be surgically

Who is the study for?

This trial is for individuals with high-grade gliomas, a type of brain tumor including anaplastic astrocytoma and astrocytoma. It's aimed at those whose tumors have come back or are getting worse, whether they can be surgically removed or not.

What is being tested?

The study is testing a combination treatment using DB107-RRV (a retroviral replicating vector) and DB107-FC (flucytosine in tablet form) to see if it can shrink the tumors and help control the disease longer.

What are the potential side effects?

Potential side effects aren't specified here but may include typical reactions to gene therapy vectors such as fever, headache, nausea, or more serious immune responses. Flucytosine could cause digestive upset or blood abnormalities.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly able to care for myself.

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I am between 18 and 75 years old.

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My high-grade glioma has come back or gotten worse.

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I have a high-grade glioma that cannot be surgically removed.

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My MRI shows a measurable area of disease that is at least 1 cm in two different dimensions.

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My blood test shows I have the DGM7 biomarker.

Exclusion Criteria

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

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I plan to use or have recently used Gliadel® wafer during surgery.

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I have a stomach or intestine condition that affects how I absorb medicine.

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My glioma cannot be biopsied or treated with DB107-RRV due to multiple locations.

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My brain cancer has come back more than twice.

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My diagnosis is oligodendroglioma or mixed gliomas.

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My kidney function is reduced.

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I have not recently used drugs that affect my bone marrow.

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I have a bleeding disorder or am currently on blood thinners.

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I have been taking more than 8 mg of dexamethasone daily for over a month.

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I have not needed antibiotics or antivirals for an infection in the last 4 weeks.

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I currently have COVID-19.

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I have difficulty making decisions due to my health condition.

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I have a history of HIV or severe weakening of my immune system.

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

Study Objectives

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

Primary study objectives

Overall Survival

Progression Free Survival

Secondary study objectives

Assessment of Tumor Status Measured by Response Assessment in Neuro-oncology (RANO) Criteria

Durable Clinical Benefit Rate (DCBR)

Durable Response Rate (DRR)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: DB107-RRV and DB107-FC GroupExperimental Treatment2 Interventions

Patients will receive DB107-RRV during the tumor resection/biopsy procedure. Approximately 6 weeks after surgery, patients will start drug therapy with a 7-day oral regimen of 220 mg/kg/day DB107-FC, which is to be self-administered. This 7-day regimen, which is considered one cycle of treatment, is to be repeated every 6 weeks for up to 12 months. Patients will undergo follow up procedures for at least 5 years after last DB107-RRV treatment.

0 / 19Eligibility criteria met

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Who is running the clinical trial?

Ashish ShahLead Sponsor

Denovo Biopharma LLCIndustry Sponsor

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,967 Total Patients Enrolled

~22 spots leftby May 2034

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