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CAN-2409 · BrTK02

Phase 2a Study of CAN-2409 With Standard Radiation Therapy for Malignant Glioma

Ensayo de Candel Therapeutics, Inc. en Malignant Glioma · Glioblastoma Multiforme · Anaplastic Astrocytoma · High Grade Glioma (del registro, en inglés).

Más ensayos de: Glioblastoma.

Fase

Fase 2

Estado

Completado

Participantes

52

previstos

Centros

4

Fin del objetivo primario

dic 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2007.

Qué mide

Number of Participants With Treatment Related Adverse Events (del registro, en inglés) (2 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study was to evaluate the safety and potential efficacy of CAN-2409 (also known / previously described as AdV-tk, GMCI) for malignant gliomas. The approach used an adenoviral vector (disabled virus) engineered to express the Herpes thymidine kinase gene (aglatimagene besadenovec, CAN-2409), followed by an antiherpetic prodrug, valacyclovir. CAN-2409 was injected into the resection bed after standard tumor surgery and valacyclovir pills were taken for 14 days. Standard radiation and chemotherapy were administered which have been shown to work cooperatively with CAN-2409 + prodrug to kill tumor cells. The hypothesis is that this combination therapy can be safely delivered and will lead to improvement in the clinical outcome for patients with newly diagnosed malignant gliomas, including glioblastoma multiforme (WHO grade IV) and anaplastic astrocytomas (WHO grade III).

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Ficha completa en ClinicalTrials.gov (NCT00589875), actualizada en mar 2024.