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Anti-metabolites

DB107-RRV and DB107-FC Group for Brain Tumor

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival

Progression Free Survival

Secondary outcome measures

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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ashish ShahLead Sponsor

Denovo Biopharma LLCIndustry Sponsor

National Cancer Institute (NCI)NIH

13,689 Previous Clinical Trials

40,930,428 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"As per the details available on clinicaltrials.gov, recruitment for this particular trial is presently closed. The study was initially listed on May 1st, 2024, and last updated on February 8th, 2024. Despite this trial being inactive in terms of candidate enrollment at present, there are currently 118 other studies actively seeking participants."

Answered by AI

What are the specific criteria for individuals who can participate in this medical study?

"Patients aged between 18 and 75 years diagnosed with anaplastic astrocytoma are eligible for inclusion in this trial, which aims to enroll approximately 33 participants."

Answered by AI

What is the primary objective of conducting this clinical trial?

"The primary aim of this clinical investigation, to be evaluated for a duration of approximately up to 24 months, is the assessment of overall survival. Secondary endpoints encompass determining the Duration of Durable Response Rate described as the total number of patients exhibiting complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) at one year post-treatment initiation; evaluating Tumor Status via Response Assessment in Neuro-oncology (RANO) Criteria which involves assessing radiological response based on CR, PR, SD, or PD following RANO criteria guidelines in participants with recurrent high-grade gliomas; and quantifying Treatment"

Answered by AI

Have the groups DB107-RRV and DB107-FC received approval from the FDA?

"Based on the current Phase 2 trial status, our evaluation at Power rates the safety of DB107-RRV and DB107-FC Group as a 2. This indicates that while some safety data is available, there is currently no evidence supporting efficacy."

Answered by AI