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New treatment option for Malignant Glioma of Brain
Official title Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.
ClinicalTrials.gov ID: NCT05686798
What this study is testing
What is Ad5-yCD/mutTKSR39rep-ADP adenovirus and fractionated stereotactic radiosurgery (fSRS)?
Ad5-yCD/mutTKSR39rep-ADP adenovirus and fractionated stereotactic radiosurgery (fSRS) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for malignant glioma of brain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary goal of this Phase I study is to determine the maximum tolerated dose of oncolytic adenovirus mediated double suicide-gene therapy in combination with fractionated stereotactic radiosurgery in patients with recurrent high-grade astrocytoma undergoing resection.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people with radiologic evidence of intracranial recurrence or progression of a previously diagnosed high-grade astrocytoma. To be eligible for this...
- Histologically documented glioblastomas or anaplastic astrocytoma prior to the debulking surgery that is suspicious to have progressed on imaging. An...
- Patients must be ≥ 18 years of age, able to provide informed consent and express a willingness to meet all the expected requirements of the protocol...
- Must have recovered from toxicity (grade 2 or less) of prior therapy.
- Eligible for partial or total resection of the recurrent tumor
You likely can't join if
- Acute infection. Acute infection is defined by any viral, bacterial, or fungal infection that has required active treatment and caused oral...
- Serum antibodies to human immunodeficiency virus (HIV)
- Previous history of liver disease including autoimmune or viral hepatitis
- Positive serologic test for Hepatitis B or C at baseline
- Immunosuppressive therapy except for corticosteroid use
- Serious medical or psychiatric illness or concomitant medication, which, in the judgment of the investigator, might interfere with the subject's...
See the full eligibility criteria
- people with radiologic evidence of intracranial recurrence or progression of a previously diagnosed high-grade astrocytoma. To be eligible for this trial, the people must have:
- Histologically documented glioblastomas or anaplastic astrocytoma prior to the debulking surgery that is suspicious to have progressed on imaging. An interval of at least 3 months must have elapsed since the completion...
- Patients must be ≥ 18 years of age, able to provide informed consent and express a willingness to meet all the expected requirements of the protocol for the duration of the study.
- Must have recovered from toxicity (grade 2 or less) of prior therapy.
- Eligible for partial or total resection of the recurrent tumor
- No anticipated physical connection between post-resection tumor cavity and cerebral ventricle
- Karnofsky performance status (KPS) ≥ 60 at time of surgery
- No prior treatment of the tumor with gene or virus therapy, immunotherapy, brachytherapy, or implants of polymers containing chemotherapeutic agents (e.g. Gliadel Wafer)
- No immunosuppressive or immune disorder
- Baseline organ function testing intact
- Patients who are candidates for surgical debulking (re-resection) following recurrence of diseases based on multidisciplinary evaluation by neurosurgeons, radiation oncologists, neuro-radiologists, and neuro-oncologists.
- people must have adequate baseline organ function, as assessed by the following laboratory values, within 30 days before initiating the study therapy:
- Adequate renal function with creatinine clearance ≥ 50 mL/min/m2
- Platelet count ≥ 100,000/μL
- Absolute neutrophil count ≥ 1,000/μL
- Hemoglobin \> 10.0 g/dL
- Bilirubin \< 1.5 mg/dL; SGOT and SGPT \< 2.5 times upper limit of normal (ULN).
- Women of child-bearing potential will be required to practice birth control for the duration of the treatment and for at least 90 days after surgery with intratumor virus inoculation. Men must use barrier protection for...
- Acute infection. Acute infection is defined by any viral, bacterial, or fungal infection that has required active treatment and caused oral temperature \>38.5oC and/or clinically significant leukocytosis
- Serum antibodies to human immunodeficiency virus (HIV)
- Previous history of liver disease including autoimmune or viral hepatitis
- Positive serologic test for Hepatitis B or C at baseline
- Immunosuppressive therapy except for corticosteroid use
- Serious medical or psychiatric illness or concomitant medication, which, in the judgment of the investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial
- Impaired immunity or susceptibility to serious viral infections
- Pregnant or lactating females
- Allergy to any product used on the protocol
- Patient is not able to undergo a brain MRI.
- Patients who are not eligible for debulking surgery or resection of recurrent disease will be considered ineligible.
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.