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New treatment option for Low Grade Glioma of Brain
Official title ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas
ClinicalTrials.gov ID: NCT05609994
What this study is testing
What is PEPIDH1M vaccine + vorasidenib?
PEPIDH1M vaccine + vorasidenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for low grade 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 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.
- 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
- 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
You likely can't join if
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years (e.g., carcinoma in situ of the breast, oral...
- 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.
See the full eligibility 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
- 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...
- 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...
- Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. people with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted (Note: Patients with...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, 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 Durham, North Carolina, 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.