A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Candel Therapeutics, Inc.
Study ID
NCT00634231
Phase
PHASE1
Status
Completed

Conditions

  • Malignant Glioma
  • Recurrent Ependymoma

Eligibility Criteria

Sex
ALL
Age
3 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • AdV-tk — BIOLOGICAL
  • valacyclovir — DRUG
  • Radiation — RADIATION

Study Details

This study will evaluate the administration of AdV-tk followed by valacyclovir in children with malignant glioma, including glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), as well as recurrent ependymomas in combination with radiation therapy. The primary objective is to determine if this approach is safe and can be effectively delivered without disturbing standard therapy.

Key Dates

Start date
Oct 31, 2010
Status verified
Aug 2023
Primary completion
Dec 31, 2015
Completion
Jun 30, 2021

Study Design

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

Arms

  • Experimental: AdV-tk
    AdV-tk + valacyclovir in combination with standard of care radiation

Primary Outcome Measure

Incidence of treatment emergent adverse events [ Time Frame: 2 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Children's Hospital of Chicago (Formerly Children's Memorial Hospital)ChicagoIllinois60611-
Dana-Farber Cancer InstituteBostonMassachusetts02115-

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