Durham, NCNCT05609994Now EnrollingIRB Ready

Low Grade Glioma of Brain Clinical Trial in Durham, NC

Access cutting-edge low grade glioma of brain treatment through this phase 1 clinical trial at a research site in Durham. Study-provided care at no cost to qualified participants.

Sponsored by Katy Peters, MD, PhD

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Expert Care in Durham

Access low grade glioma of brain specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related low grade glioma of brain treatment provided free

Apply for This Durham Location

Check if you qualify for this low grade glioma of brain clinical trial in Durham, NC

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Durham

    Convenient for NC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Durham site if eligible
  4. 4Begin participation

About This Low Grade Glioma of Brain Study in Durham

The purpose of this study is to determine the safety and efficacy of a PEPIDH1M vaccine in combination with vorasidenib, a dual inhibitor of mutant IDH1 and IDH2 enzymes, in adult patients diagnosed with recurrent IDH1 mutant lower grade gliomas.

Sponsor: Katy Peters, MD, PhD

Who Can Participate

Inclusion Criteria

Age ≥ 18 years
IDH1R132H expression in primary tumor
Clinical and/or radiographic, progressive Grade 2-3 glioma with greater than 2 cm of non-enhancing disease in one plane.
1st recurrence only
Signed informed consent
For females of child-bearing potential, negative serum pregnancy test at screening
Women of childbearing potential and male participants must agree to practice contraception
Karnofsky Performance Status (KPS) of ≥ 70
Expected survival of ≥ 12 months
Recovered from any clinically relevant toxicities associated with any prior surgery for the treatment of glioma unless stabilized under medical management
Complete Blood Count (CBC)/differential with adequate bone marrow function as defined below within 2 weeks of enrollment:
Absolute neutrophil count (ANC) ≥ 1000 cells/mm3
Platelet count ≥ 100,000 cells/mm3
Hemoglobin (Hgb) ≥ 10 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10 g/dl is acceptable.)
Adequate renal function as defined below within 2 weeks of enrollment:
Blood urea nitrogen (BUN) ≤ 25 mg/dl
Creatinine ≤ 1.7 mg/dl
Adequate hepatic function as defined below within 2 weeks of enrollment:
Bilirubin ≤ 2.0 mg/dl
Alanine transaminase (ALT) ≤ 3 x normal range
Aspartate aminotransferase (AST) ≤ 3 x normal range

Exclusion Criteria

Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years (e.g., carcinoma in situ of the breast, oral cavity, and cervix are all permissible)
Metastases detected below the tentorium or beyond the cranial vault
More than 1 cm X 1 cm of enhancing disease on gadolinium contrasted MRI imaging
Severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization
Myocardial infarction within the last 6 months.
Known Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition (Note: human immunodeficiency virus \[HIV\] testing is not required for entry into this protocol. The need to exclude patients with Acquired Immunodeficiency Syndrome (AIDS) from this protocol is necessary because treatments involved in this protocol may be significantly immunosuppressive.)
Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug
Patients with a heart-rate corrected QT interval using Fridericia's formula (QTcF) ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome)
Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Subjects with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted (Note: Patients with chronic HBV that is adequately suppressed by institutional practice will be permitted.)
Patients with active gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition that limits the ingestion or gastrointestinal absorption of drugs administered orally (Note: Gastroesophageal reflux disease under medical treatment is allowed.)
Patient taking any medications that are CYP3A or CYP2C9 substrates with a narrow therapeutic index (Note: Patients should be transferred to other medications before receiving the first dose of study drug.)
Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study
Patients with known hypersensitivity to GM-CSF, yeast-derived products, or any component of Leukine®
Allergy or hypersensitivity to tetanus vaccine or any component of the tetanus vaccine.
Known hypersensitivity to any component of vorasidenib
Prior therapy with mIDH1 targeted therapeutics
Unable to undergo MRI imaging

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 Durham?

Yes, this clinical trial (NCT05609994) has an active research site in Durham, NC 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.

Low Grade Glioma of Brain Treatment Options in Durham, NC

If you're searching for low grade glioma of brain treatment options in Durham, NC, this clinical trial (NCT05609994) 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 Durham research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced low grade 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 low grade glioma of brain clinical trials near you to find additional studies recruiting in your area.

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