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NCT00589875 · ClinicalTrials.gov registry record · Phase 2
Phase 2a Study of CAN-2409 With Standard Radiation Therapy for Malignant Glioma
A Phase 2 study, sponsored by Candel Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT00589875 is a Phase 2 study that has completed, run by Candel Therapeutics. The registered enrollment target is 52 participants.
The verdict
NCT00589875, a Phase 2 study, has completed, sponsored by Candel Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
The 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).
Interventions
- DRUG Temozolomide
- RADIATION Radiation therapy
- DRUG Valacyclovir
- BIOLOGICAL CAN-2409
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2007-03 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00589875
The ClinicalTrials.gov registry entry for NCT00589875 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Candel Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Temozolomide is the first listed.
NCT00589875 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00589875 about?
NCT00589875 is a clinical study titled "Phase 2a Study of CAN-2409 With Standard Radiation Therapy for Malignant Glioma". The 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,...
What is the current status of trial NCT00589875?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2007-03. Estimated completion is 2016-08.
What interventions are being tested in trial NCT00589875?
The interventions under investigation include: Temozolomide (DRUG), Radiation therapy (RADIATION), Valacyclovir (DRUG), CAN-2409 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00589875?
This trial is sponsored by Candel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
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