Phase 2 N=52 Treatment

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

Malignant Glioma · Glioblastoma Multiforme · Anaplastic Astrocytoma · High Grade Glioma

Bottom Line

View on ClinicalTrials.gov: NCT00589875 ↗

Enrolled (actual)

Serious AEs

46.5%

Results posted

Apr 2024

Primary outcome: Primary: Number of Participants With Treatment Related Adverse Events — 21 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CAN-2409 (Biological); Valacyclovir (Drug); Temozolomide (Drug); Radiation therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Candel Therapeutics, Inc.
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment Related Adverse Events	21	—
SECONDARY Overall Survival	18.15	—

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).

Eligibility Criteria

Inclusion Criteria

Patients must have presumed resectable or partially resectable malignant glioma based on clinical and radiologic evaluation (pathologic confirmation of malignant glioma must be made at the time of surgery if not previously determined). Patients who have previously received CAN-2409 + prodrug on this study may receive an additional CAN-2409 + prodrug course at recurrence if eligibility criteria are still met.
Tumor must be accessible for injection and must not be located in the brainstem, midbrain, contained within the ventricular system, or located in an infratentorial location.
Upfront patients must be planning to undergo standard radiation therapy.
Patients must be 18 years of age or older.
Performance status must be KPS ≥70.
Patients must have SGOT (AST) 10ml/min.
Patients must have platelets > 100, 000/mm3 and WBC > 3000/mm3.
Patients of reproductive age must agree to use a medically accepted form of birth control while on the study.
Patients must give study specific informed consent prior to enrollment. For re-administration, patients must be re-consented.
Patients must be able to tolerate MRI scan procedure

Exclusion Criteria

Active liver disease including cirrhosis or hepatitis
Patients on immunosuppressive drugs (with exception of corticosteroid)
Known HIV+ patients.
Patients with acute infections (viral, bacterial or fungal infections requiring therapy).
Pregnant or breast feeding patients. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy.
Evidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers).
Other serious co-morbid illness or compromised organ function.
Patients may not receive chemotherapy until valacyclovir is completed and may not receive other investigational anti-tumor agents within 30 days prior to study entry or during active participation in the study (defined as from CAN-2409 injection until tumor progression).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00589875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.