Is NCT05686798 recruiting in Detroit, MI?

Yes, NCT05686798 is currently recruiting participants at its Detroit, MI location. This malignant glioma of brain clinical trial is actively enrolling qualified participants.

How do I join the malignant glioma of brain clinical trial in Detroit?

To join this clinical trial in Detroit, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Detroit clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Malignant Glioma of Brain Clinical Trial in Detroit, MI

About This Malignant Glioma of Brain Study in Detroit

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.

Sponsor: Henry Ford Health System

Who Can Participate

Inclusion Criteria

Subjects with radiologic evidence of intracranial recurrence or progression of a previously diagnosed high-grade astrocytoma. To be eligible for this trial, the subjects 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 of the most recent course of radiation while at least 4 weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy regimen and at least 6 weeks since the completion of a nitrosourea containing chemotherapy regimen.

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.

Subjects 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 the duration of treatment and for at least 90 days after surgery with intratumor virus inoculation treatment.

Exclusion Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Detroit?

Yes, this clinical trial (NCT05686798) has an active research site in Detroit, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Malignant Glioma of Brain Treatment Options in Detroit, MI

If you're searching for malignant glioma of brain treatment options in Detroit, MI, this clinical trial (NCT05686798) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Detroit research site is actively enrolling participants for this clinical trial. You'll receive care from experienced malignant glioma of brain specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all malignant glioma of brain clinical trials near you to find additional studies recruiting in your area.

Malignant Glioma of Brain Clinical Trial in Detroit, MI

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