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

Part of paid clinical trials in Duarte, California.

Sponsor
Candel Therapeutics, Inc.
Study ID
NCT00589875
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CAN-2409 — BIOLOGICAL
    Single dose of 3x10e11 vector particles of CAN-2409 delivered to the tumor bed after resection on day 0.
  • Valacyclovir — DRUG
    Single course of valacyclovir at dose of 2 grams orally three times per day for 14 days starting on day 1-3
  • Temozolomide — DRUG
    Concomitant TMZ will be administered orally once a day at a dose of 75 mg/m2 starting the next day after completing prodrug and continued for 6 weeks. Adjuvant TMZ will be administered days 1 to 5 of a 28-day cycle for 6 cycles with 150 mg/m2 administered for cycle 1, and 150 to 200 mg/m2 administered for cycles 2 to 6. Adjuvant treatment will start 1 month following completing RT.
  • Radiation therapy — RADIATION
    Radiation will be administered to up-front patients as per standard of care for the patient. It will start 3-7 days after CAN-2409 injection, preferably closer to 3 days. It will consist of standard external field radiation, limited to the area of tumor and brain adjacent to tumor, fractionated at doses of 200cGy per day for approximately 6 weeks to a total of 5500-6000 cGy.

Study Details

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).

Key Dates

Start date
Mar 31, 2007
Status verified
Mar 2024
Primary completion
Dec 31, 2015
Completion
Aug 31, 2016

Study Design

Enrollment
52 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm
    This study is an extension of evaluation of the surgical resection arm, Arm B, from a phase Ib study in which dose escalation on arm B was completed.

Primary Outcome Measure

Number of Participants With Treatment Related Adverse Events [ Time Frame: 2 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
The University of ChicagoChicagoIllinois60637-
The Ohio State University Medical Center, Dept. Neurological SurgeryColumbusOhio43210-
The Methodist Hospital Neurological InstituteHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAThe University of Chicago· Chicago, ILThe Ohio State University Medical Center, Dept. Neurological Surgery· Columbus, OHThe Methodist Hospital Neurological Institute· Houston, TX

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