AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01)

Part of paid clinical trials in Duarte, California.

Sponsor
Candel Therapeutics, Inc.
Study ID
NCT00638612
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • AdV-tk — BIOLOGICAL
    Four dose levels of AdV-tk with a fixed dose level of valacyclovir are evaluated independently in the two arms of the study due to differences in the concomitant standard of care treatments. The first AdV-tk course is given prior to surgery or radiation by CT or EUS guided injection into the tumor followed by 14 days of valacyclovir. The second AdV-tk injection is into the tumor bed at the time of surgery in Arm A or same as the first injection in Arm B again followed by 14 days of valacyclovir. The AdV-tk dose levels are: Level 1= 3x10e10 vector particles (vp), Level 2= 1x10e11 vp, Level 3= 3x10e11 vp, Level 4= 1x10e12 vp
  • Valacyclovir — DRUG
    Valacyclovir caplets at a dose of 2 grams orally three times per day is administered for 14 days starting 1-3 days after each of the two AdV-tk injections in both arms.

Study Details

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.

Key Dates

Start date
Aug 31, 2008
Status verified
Aug 2023
Primary completion
May 31, 2013
Completion
Jun 30, 2015

Study Design

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

Arms

  • Experimental: A resectable
    Arm A is for resectable tumors. The first AdV-tk course is given prior to surgery by CT or EUS guided injection into the tumor followed by 14 days of valacyclovir. The second AdV-tk injection is into the tumor bed at the time of surgery again followed by 14 days of valacyclovir.
  • Experimental: B locally advanced
    Arm B is for locally advanced tumors for which chemoradiation is the planned standard of care treatment. AdV-tk is delivered by CT or EUS guided injection into the tumor. The first AdV-tk injection is given prior to starting chemoradiation and the second in week 3 of chemoradiation. Both injections are followed by 14 days of valacyclovir. Enrollment has been completed for Arm B.

Primary Outcome Measure

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

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
Scripps Green Hospital/Scripps Cancer CenterLa JollaCalifornia92037-
The Ohio State UniversityColumbusOhio43210-

Find similar trials in Duarte, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
City of Hope Medical Center· Duarte, CAScripps Green Hospital/Scripps Cancer Center· La Jolla, CAThe Ohio State University· Columbus, OH

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