Phase 1b Study of AdV-tk + Valacyclovir Combined With Radiation Therapy for Malignant Gliomas

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Candel Therapeutics, Inc.
Study ID
NCT00751270
Phase
PHASE1
Status
Completed

Conditions

  • Anaplastic Astrocytoma
  • Glioblastoma Multiforme
  • Malignant Glioma

Eligibility Criteria

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

Interventions

  • AdV-tk — BIOLOGICAL
    Three different dosing levels of AdV-tk (3x10e10, 1x10e11, 3X10e11) were evaluated. A single injection of AdV-tk at the assigned dose level was administered, followed by 14 days of the oral prodrug valacyclovir. Patients then received standard of care radiation therapy and chemotherapy.
  • Valacyclovir — DRUG
    The oral prodrug valacyclovir was given beginning 1-3 days following the AdV-tk. Valacyclovir tablets were taken three times a day for a total of 14 days.

Study Details

This phase I study evaluated a Gene Mediated Cytotoxic Immunotherapy approach for malignant gliomas, including glioblastoma multiforme and anaplastic astrocytoma. The purpose of this study was to assess the safety and feasibility of delivering an experimental approach called GliAtak which uses AdV-tk, an adenoviral vector containing the Herpes Simplex thymidine kinase gene, plus an oral anti-herpetic prodrug, valacyclovir, in combination with standard of care radiation.

Key Dates

Start date
Nov 30, 2005
Status verified
Aug 2023
Primary completion
Jan 31, 2010
Completion
Jan 31, 2011

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: A
    Arm A for unresectable malignant glioma was closed due to poor accrual.
  • Experimental: B
    Arm B for resectable malignant glioma completed the Phase I accrual and long term follow up continues. A follow on study at dose level 3 was opened as a Phase 2a study (see BrTK02).

Primary Outcome Measure

Incidence of treatment emergent adverse events [ Time Frame: Through month 3 and long term follow up for late effects. ]

Locations (2)

FacilityCityStateZIPSite coordinators
The Ohio State University Medical Center, Dept NeurosurgeryColumbusOhio43210-
The Methodist HosptialHoustonTexas77030-

Find similar trials in Columbus, OH

By research site
The Ohio State University Medical Center, Dept Neurosurgery· Columbus, OHThe Methodist Hosptial· Houston, TX

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