AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01) (PaTK01)
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ClinicalTrials.gov Identifier: NCT00638612 |
Recruitment Status :
Completed
First Posted : March 19, 2008
Last Update Posted : October 29, 2015
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Condition or disease | Intervention/treatment | Phase |
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Pancreatic Adenocarcinoma Pancreatic Cancer | Biological: AdV-tk Drug: Valacyclovir | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | AdV-tk + Valacyclovir Therapy in Combination With Surgery and Chemoradiation for Pancreas Cancer |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
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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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Biological: AdV-tk
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 Drug: Valacyclovir 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 Name: Valtrex |
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. |
Biological: AdV-tk
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 Drug: Valacyclovir 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 Name: Valtrex |
- Safety based on symptoms and laboratory abnormalities not expected from standard of care treatments or natural history of the disease process. Toxicity grading uses NCI CTC version 3. Dose limiting toxicity is specifically defined in the protocol. [ Time Frame: 2 months ]
- Overall survival [ Time Frame: 2 years ]
- Progression free survival [ Time Frame: 2 years ]
- Tumor response including pathologic response [ Time Frame: 2 months ]
- Quality of life [ Time Frame: 2 years ]
- Resectability [ Time Frame: 2 years ]
- CA 19-9 response [ Time Frame: 2 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638612
United States, California | |
City of Hope Medical Center | |
Duarte, California, United States, 91010 | |
Scripps Green Hospital/Scripps Cancer Center | |
La Jolla, California, United States, 92037 | |
United States, Ohio | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Mark Bloomston, MD | Ohio State University |
Responsible Party: | Candel Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00638612 |
Other Study ID Numbers: |
PaTK01 |
First Posted: | March 19, 2008 Key Record Dates |
Last Update Posted: | October 29, 2015 |
Last Verified: | October 2015 |
Immunotherapy Gene Therapy Cytotoxicity Tumor vaccine |
Radiation Surgery Chemoradiation |
Pancreatic Neoplasms Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Pancreatic Diseases |
Digestive System Diseases Endocrine System Diseases Valacyclovir Antiviral Agents Anti-Infective Agents |