Is NCT06914479 recruiting in Ann Arbor, MI?

Yes, NCT06914479 is currently recruiting participants at its Ann Arbor, MI location. This recurrent diffuse hemispheric glioma, h3 g34-mutant clinical trial is actively enrolling qualified participants.

Is participation in this Ann Arbor 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.

Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant Clinical Trial in Ann Arbor, MI

Q: How do I join the recurrent diffuse hemispheric glioma, h3 g34-mutant clinical trial in Ann Arbor?

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

About This Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant Study in Ann Arbor

This phase I trial tests the safety, side effects and best dose of AdV-HSV1-TK and AdV-Flt3L in combination with valacyclovir for the treatment of patients with primary cancerous (malignant) brain tumors that can be removed by surgery (resectable) and that have come back after a period of improvement (recurrent). AdV-HSV1-TK and AdV-Flt3L use a virus modified in the laboratory to kill tumor cells and stimulate the immune system to recognize the tumor cells as "invaders" which can lead to tumor shrinkage. For this process to work, an oral anti-herpes medication called valacyclovir is also needed. Giving AdV-HSV1-TK, AdV-Flt3L and valacyclovir may be safe, tolerable and/or effective in treating patients with resectable, recurrent primary malignant brain tumors.

Sponsor: University of Michigan Rogel Cancer Center

Who Can Participate

Inclusion Criteria

Age 3 to 25 years with:

Diagnosis of malignant primary brain tumor after tumor recurrence, relapse, or progression who have completed up-front, standard-of-care therapy

Age 26 to 39 years with:

Diagnosis of diffuse hemispheric glioma, H3 G34-mutant, per 2021 World Health Organization (WHO) classification, after tumor recurrence, relapse, or progression who have completed up-front, standard-of-care therapy

At least 10 kg (and body surface area \[BSA\] \> 0.5 m\^2)

Participants who are receiving corticosteroids must be on a stable or decreasing dose for at least 3 days prior to baseline MRI

Surgical resection of the tumor recurrence/relapse/progression is clinically indicated at the time of enrollment

A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate

Participant must be willing to provide archival formalin-fixed embedded (FFPE) and/or frozen tissue specimens, if available

Participant must have recovered from all acute side effects of prior therapy.

From the projected start of scheduled study treatment, the following time periods must have elapsed: At least 7 days after last dose of a biologic agent or beyond time during which adverse events are known to occur for a biologic agent, 5 half-lives from any investigational agent, 4 weeks from cytotoxic therapy (except 23 days for temozolomide and 6 weeks from nitrosoureas), 6 weeks from antibody therapy (21 days for bevacizumab,.6 weeks from cellular therapy (i.e. modified T cells, natural killer \[NK\] cells, dendritic cells, etc.), or 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies

For participants who have received radiotherapy previously, participants must be at least 28 days from focal radiation therapy, at least 150 days from craniospinal irradiation therapy.

The use of bevacizumab to control radiation therapy-induced edema is allowed prior to or during study therapy (if used for tumor-directed therapy, please see required washout period above).

Dosing limitations are as follows:

Bevacizumab (or bioequivalent) for up to a maximum of 5 doses, dosing per institutional standard. There is no required washout period

Prior use of temozolomide during radiation at maximum of the standard pediatric dosing (defined as 90 mg/m\^2/dose continuously during radiation therapy) or dexamethasone is allowed

Peripheral absolute neutrophil count (ANC) ≥ 1000/mm\^3 (1.0g/l)

Platelet count ≥ 100,000/mm\^3 (100x10\^9/l) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)

Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70mL/min/1.73 m\^2 or a serum creatinine within the normal limits for age

Bilirubin (sum of conjugated + unconjugated) ≤ 2 x upper limit of normal (ULN) for age

Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x ULN

Serum albumin ≥ 2 g/dL

Performance score ≥ 60 (Karnofsky for participants \> 16 years of age, Lansky for participants ≤ 16 years of age.)

Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score

The effects of the study drugs on the developing human fetus are unknown. For this reason, females of child-bearing potential (FOCBP) and males must agree to use adequate contraception for the duration of study participation and 30 days after last dose of AdV-HSV1-TK/AdV-Flt3L or valacyclovir, whichever is later.

Adequate methods include hormonal or barrier method of birth control, or abstinence at the time of study entry and for the duration of study participation.

Should a participant become pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately.

Males treated on this study must also agree to use adequate contraception as of the time of enrollment onto the study and for the duration of study participation. Male participants must notify the treating physician immediately if his partner becomes pregnant while he is receiving study therapy

Exclusion Criteria

Patient deemed not clinically appropriate to undergo tumor tissue resection by a neurosurgeon

Evidence of disseminated disease, including diffuse leptomeningeal disease or evidence of cerebrospinal fluid (CSF) dissemination

Patient with primary brainstem or primary spinal tumors

History of prior gene therapy

Ongoing therapy with valacyclovir that is unable to be stopped due to a medical condition

Known allergy to valacyclovir

Concurrent use of other investigational agents.

Participants who are currently receiving another investigational drug. Investigational imaging agents or agents used to enhance tumor visibility on imaging or during tumor biopsy/resection should be discussed with the study chairs

Participants who are currently receiving anti-cancer agents

Participants with a known disorder that affects their immune system, such as HIV or hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy

Presence of uncontrolled infection or other uncontrolled systemic illness

Current diagnosis of bipolar disorder or major depressive disorder

Presence of a congenital immune deficiency syndrome or acquired autoimmune disease

Female participants of childbearing potential must not be pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine or serum pregnancy test prior to the start of therapy (as clinically indicated)

Active illicit drug use or diagnosis of alcoholism

History of kidney transplant

History of allogeneic stem cell transplantation

Known additional malignancy that is progressing or requires active treatment within 3 years of start of study drug

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 Ann Arbor?

Yes, this clinical trial (NCT06914479) has an active research site in Ann Arbor, 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.

Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant Treatment Options in Ann Arbor, MI

If you're searching for recurrent diffuse hemispheric glioma, h3 g34-mutant treatment options in Ann Arbor, MI, this clinical trial (NCT06914479) 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 Ann Arbor research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced recurrent diffuse hemispheric glioma, h3 g34-mutant 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 recurrent diffuse hemispheric glioma, h3 g34-mutant clinical trials near you to find additional studies recruiting in your area.

Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant Clinical Trial in Ann Arbor, MI

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