- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00638612
AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01) (PaTK01)
August 23, 2023 updated by: Candel Therapeutics, Inc.
AdV-tk + Valacyclovir Therapy in Combination With Surgery and Chemoradiation for Pancreas Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Duarte, California, United States, 91010
- City of Hope Medical Center
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La Jolla, California, United States, 92037
- Scripps Green Hospital/Scripps Cancer Center
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Must have presumed pancreatic adenocarcinoma based on clinical and radiologic evaluation with identifiable tumor accessible for injection (pathologic diagnosis of pancreatic adenocarcinoma must be made prior to AdV-tk injection
- For Arm A, resectable disease. Arm B for locally advanced disease has completed accrual.
- Performance status must be ECOG 0-2
- SGOT (AST)<3x upper limit of normal
- Serum creatinine<2mg/dl and calculated creatinine clearance >10ml/min
- Platelets>100,000/mm3 and WBC>3000/mm3 and ANC>1500/mm3
- Must give study specific informed consent prior to enrollment
Exclusion Criteria:
- Primary hepatic dysfunction including active hepatitis but not to exclude patients due to obstructive jaundice. If obstructive jaundice is clinically significant, bilirubin should be stable or decreasing prior to enrollment.
- Evidence of clinically significant pancreatitis as determined by the investigator.
- Patients on corticosteroids or other immunosuppressive drugs
- Known HIV+ patients
- Patients with acute infections (viral, bacterial or fungal infections requiring therapy)
- Pregnant or breast-feeding patients. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy
- Evidence of distant metastatic disease at the time of enrollment or other malignancy (except squamous or basal cell skin cancers) and no prior abdominal radiation therapy or prior treatment for pancreatic cancer
- Other serious co-morbid illness or compromised organ function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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 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.
Other Names:
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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. |
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 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of treatment emergent adverse events
Time Frame: 2 months
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2 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Overall survival
Time Frame: 2 years
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2 years
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Progression free survival
Time Frame: 2 years
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2 years
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Tumor response including pathologic response
Time Frame: 2 months
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2 months
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Functional Assessment of Cancer Therapy - Pancreas (FACT-Hep)
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark Bloomston, MD, Ohio State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
March 6, 2008
First Submitted That Met QC Criteria
March 13, 2008
First Posted (Estimated)
March 19, 2008
Study Record Updates
Last Update Posted (Actual)
August 25, 2023
Last Update Submitted That Met QC Criteria
August 23, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PaTK01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Cancer
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City of Hope Medical CenterRecruitingPancreatic Neoplasms | Pancreatic Cancer | Pancreatic Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | Pancreatic Cancer Resectable | Pancreatic Carcinoma | Pancreatic Cancer Non-resectable | Pancreatic Cancer Stage III | Pancreatic Cancer Stage | Pancreatic Cancer Stage II | Pancreatic Cancer, Adult | Pancreatic... and other conditionsKorea, Republic of, United States, Japan
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