Clinical trialPhase 1Completed
AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01)
AdV-tk + Valacyclovir Therapy in Combination With Surgery and Chemoradiation for Pancreas Cancer
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- August 2008
- Expected end
- June 2015
- Enrollment
- 27 participants
- Sites
- 3
- Primary outcomes
- Incidence of treatment emergent adverse events
- Sponsor
- Industry
- Results posted
- No
- Last update
- 25 August 2023
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this Phase 1 study is to evaluate the safety and potential efficacy of Gene Mediated Cytotoxic Immunotherapy for pancreatic cancer. The approach uses an adenoviral vector (disabled virus) engineered to express the Herpes thymidine kinase gene (AdV-tk), followed by an antiherpetic prodrug, valacyclovir.
Detailed description public domain (ClinicalTrials.gov)
The AdV-tk vector is injected into the tumor or tumor bed at the time of biopsy or standard tumor surgery after which valacyclovir pills are taken for 14 days. Two courses of AdV-tk, each followed by valacyclovir, are given as adjuvant to standard of care therapies (surgery and/or chemoradiation) which have been shown to work cooperatively with AdV-tk to kill tumor cells. Arm A is for resectable tumors in which the first course is given prior to surgery and the second is at the time of surgery. Arm B is for locally advanced disease in which both AdV-tk injections are administered by needle injection into the tumor before and during chemoradiation. The hypothesis is that this combination therapy can be safely delivered and will lead to improvement in the clinical outcome for patients with pancreatic cancer.
Papers 1
- Registry-listed results paperGene-mediated cytotoxic immunotherapy as adjuvant to surgery or chemoradiation for pancreatic adenocarcinoma. DOI 10.1007/s00262-015-1679-3↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.