Valproic acid, irinotecan, and simvastatin for recurrent glioma in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, prospective study enrolling adults with recurrent glioblastoma or IDH-mutant gliomas. The treatment uses 21-day cycles with valproic acid and simvastatin given daily, and irinotecan administered on day 2 of each cycle, with ongoing simvastatin through days 3–21. The main goal is to measure tumor response by imaging to see if the regimen can produce tumor stabilization or reduction. Outcomes focus on response rate, with eligibility requiring documented progression and measurable disease, while several medical exclusions apply to limit risk. The study is conducted at Inova Schar Cancer Institute in Fairfax, Virginia, sponsored by Inova Health Care Services.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of glioblastoma or IDH-mutated glioma by WHO 2021 classification
* For glioblastoma, at least one prior treatment, which needs to include temozolomide and/or radiation
* For IDH-mutated glioma, prior treatment with both radiation and alkylating chemotherapy
* Evidence of progression by RANO 2.0 criteria on MRI within last four weeks
* At least 1 enhancing measurable lesion

Exclusion Criteria:

* Use of an enzyme-inducing antiepileptic or other strong inducer of CYP3A4
* Prior treatment with irinotecan
* Prior use of valproic acid within 2 months
* Anticancer treatment within 4 weeks, 6 weeks if nitrosourea
* Active bacterial or fungal infection requiring systemic treatment
* Pregnancy
* Known mitochondrial disease

Where it's running

• Inova Schar Cancer
  Fairfax, Virginia, United States Recruiting

Study contacts

• Principal investigator: Adam Cohen, MD — Inova Health Care Services
• Study coordinator: Keary Jane't
• Email: keary.jane't@inova.org
• Phone: (571) 472-3173

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Advanced imaging techniques for brain tumor surgery

  This study is testing if advanced imaging techniques can help doctors remove brain tumors more accurately in patients with certain types of glioblastoma to improve their outcomes.

  Recruiting Amsterdam UMC, location VUmc · Amsterdam, North Holland · NCT06623565

• YN003 injection in glioma patients

  This phase 1 study tests whether YN003 injected IV is safe and tolerable for adults with recurrent or progressive glioma, and to explore how the drug behaves in the body and any early signs of activity.

  Recruiting at 2 sites Phase 1 Beijing Inno Medicine Co., Ltd. · Los Angeles, California and 4 other locations · NCT07929909

• Brain connectome project in adults with brain glioma undergoing surgery

  This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.

  Recruiting Northwell Health · New York, New York · NCT07927595

• Lixumistat window of opportunity in newly diagnosed glioblastoma

  This study tests whether Lixumistat can benefit adults with newly diagnosed glioblastoma who are planned for surgical tumor removal.

  Recruiting Early Phase 1 University of Miami · Miami, Florida · NCT07884344

• Glioblastoma in Réunion: an epidemiological and socio-anthropological look at patients and care

  A large group of adults with diffuse gliomas in Réunion is being studied to understand how biology, culture, and health care pathways affect diagnosis and treatment.

  Recruiting Centre Hospitalier Universitaire de la Réunion · Saint-Pierre · NCT07865195

• Butterfly glioblastoma: test adding 5-ALA PoMA with LIDU ultrasound to standard care

  This early-phase study tests whether adding 5-ALA–mediated activation with LIDU ultrasound is safe and tolerable for adults with newly diagnosed butterfly glioblastoma, before or during standard chemotherapy and radiotherapy.

  Recruiting Phase 1 Alpheus Medical, Inc. · Buffalo, New York · NCT07862647

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.