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-tkAdV-tk + valacyclovir in combination with standard of care radiation
Primary Outcome Measure
Incidence of treatment emergent adverse events [ Time Frame: 2 months ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago (Formerly Children's Memorial Hospital) | Chicago | Illinois | 60611 | - |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | - |
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