VISTA: Valproic Acid, Irinotecan, and Simvastatin for Recurrent Glioma
The goal of this clinical trial is to see if the combination of valproic acid, irinotecan, and simvastatin causes these tumors to stabilize or shrink, which is a sign that these combinations are effective against tumors in patients with recurrent glioblastoma and adults with recurrent IDH-mutated gliomas
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a prospective clinical trial in two cohorts of patients, adults with recurrent glioblastoma and adults with recurrent IDH-mutated gliomas.
The study evaluates the efficacy of valproic acid, irinotecan, and simvastatin in recurrent glioma by measuring response rate.
The study treatment is as follow: Study Treatment
- 21-day cycles
- D1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily
- D2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV
- D3-21 Continuous simvastatin starting at 40mg daily PO
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Keary Jane't
- Telefonnummer: (571) 472-3173
- E-mail: keary.jane't@inova.org
Undersøgelse Kontakt Backup
- Navn: Takada Harris
- Telefonnummer: (571) 472-0618
- E-mail: takada.harris@inova.org
Studiesteder
-
-
Virginia
-
Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Inova Schar Cancer
-
Kontakt:
- Keary Jane't
- Telefonnummer: 571-472-3173
- E-mail: keary.jane't@inova.org
-
Kontakt:
- Takada Harris
- Telefonnummer: (571) 472-0618
- E-mail: takada.harris@inova.org
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Glioblastomas
Day1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily Day2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV Day3-21 Continuous simvastatin starting at 40mg daily PO |
Day 1 40mg/kg/dose PO BID and simvastatin at 40mg PO daily D2 irinotecan 180mg/m2 IV and VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily Day3-21 Continuous simvastatin starting at 40mg daily PO |
|
Eksperimentel: IDH mutated gliomas
Day1 VPA 40mg/kg/dose PO BID and simvastatin at 40mg PO daily Day2 VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily, and irinotecan 180mg/m2 IV Day3-21 Continuous simvastatin starting at 40mg daily PO |
Day 1 40mg/kg/dose PO BID and simvastatin at 40mg PO daily D2 irinotecan 180mg/m2 IV and VPA 40mg/kg/dose PO BID, simvastatin at 40mg PO daily Day3-21 Continuous simvastatin starting at 40mg daily PO |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessing Efficacy as Measured By Response Rate Of Valproic acid, Irinotecan, and Simvastatin in Recurrent Glioma
Tidsramme: through study completion, an average of 6 months from start of treatment
|
The response is defined as a confirmed complete response (CR) or partial response (PR) defined by RANO 2.0. Response rate will be calculated as the number of observed response (PR or CR) divided by all treated subjects in the arm. |
through study completion, an average of 6 months from start of treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessing Safety and Adverse Event Rates Of Valproic Acid, Irinotecan, And Simvastatin in Recurrent Glioma
Tidsramme: through end of study, average 9 months from start of treatment
|
Adverse events will be reported for all patients who receive at least one dose of study medicine. |
through end of study, average 9 months from start of treatment
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Adam Cohen, MD, Inova Health Care Services
Publikationer og nyttige links
Generelle publikationer
- Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.
- Friedman HS, Petros WP, Friedman AH, Schaaf LJ, Kerby T, Lawyer J, Parry M, Houghton PJ, Lovell S, Rasheed K, Cloughsey T, Stewart ES, Colvin OM, Provenzale JM, McLendon RE, Bigner DD, Cokgor I, Haglund M, Rich J, Ashley D, Malczyn J, Elfring GL, Miller LL. Irinotecan therapy in adults with recurrent or progressive malignant glioma. J Clin Oncol. 1999 May;17(5):1516-25. doi: 10.1200/JCO.1999.17.5.1516.
- Blaney SM, Takimoto C, Murry DJ, Kuttesch N, McCully C, Cole DE, Godwin K, Balis FM. Plasma and cerebrospinal fluid pharmacokinetics of 9-aminocamptothecin (9-AC), irinotecan (CPT-11), and SN-38 in nonhuman primates. Cancer Chemother Pharmacol. 1998;41(6):464-8. doi: 10.1007/s002800050768.
- Horbinski C, Nabors LB, Portnow J, Baehring J, Bhatia A, Bloch O, Brem S, Butowski N, Cannon DM, Chao S, Chheda MG, Fabiano AJ, Forsyth P, Gigilio P, Hattangadi-Gluth J, Holdhoff M, Junck L, Kaley T, Merrell R, Mrugala MM, Nagpal S, Nedzi LA, Nevel K, Nghiemphu PL, Parney I, Patel TR, Peters K, Puduvalli VK, Rockhill J, Rusthoven C, Shonka N, Swinnen LJ, Weiss S, Wen PY, Willmarth NE, Bergman MA, Darlow S. NCCN Guidelines(R) Insights: Central Nervous System Cancers, Version 2.2022. J Natl Compr Canc Netw. 2023 Jan;21(1):12-20. doi: 10.6004/jnccn.2023.0002.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Gliom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Glioblastom
- Astrocytom
- Organiske kemikalier
- Heterocykliske forbindelser
- Fedtsyrer
- Lipider
- Kulbrinter
- Kulbrinter, cyklisk
- Syrer, acyklisk
- Carboxylsyrer
- Camptothecin
- Alkaloider
- Naphthalenes
- Polycykliske aromatiske kulbrinter
- Kulbrinter, aromatisk
- Polycykliske forbindelser
- Pentanesyrer
- Valerates
- Fedtsyrer, flygtige
- Lovastatin
- Irinotecan
- Valproinsyre
- Simvastatin
Andre undersøgelses-id-numre
- Inova-2025-267
Plan for individuelle deltagerdata (IPD)
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