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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
Sponsor:
Information provided by (Responsible Party):
Candel Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE March 6, 2008
First Posted Date  ICMJE March 19, 2008
Last Update Posted Date October 29, 2015
Study Start Date  ICMJE August 2008
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AdV-tk Therapy With Surgery and Chemoradiation for Pancreas Cancer (PaTK01)
Official Title  ICMJE AdV-tk + Valacyclovir Therapy in Combination With Surgery and Chemoradiation for Pancreas Cancer
Brief Summary 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Adenocarcinoma
  • Pancreatic Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: AdV-tk
    • Drug: 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.

    Interventions:
    • Biological: AdV-tk
    • Drug: Valacyclovir
Publications * Aguilar LK, Shirley LA, Chung VM, Marsh CL, Walker J, Coyle W, Marx H, Bekaii-Saab T, Lesinski GB, Swanson B, Sanchez D, Manzanera AG, Aguilar-Cordova E, Bloomston M. Gene-mediated cytotoxic immunotherapy as adjuvant to surgery or chemoradiation for pancreatic adenocarcinoma. Cancer Immunol Immunother. 2015 Jun;64(6):727-36. doi: 10.1007/s00262-015-1679-3. Epub 2015 Mar 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2015)
27
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2008)
30
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00638612
Other Study ID Numbers  ICMJE PaTK01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Candel Therapeutics, Inc.
Study Sponsor  ICMJE Candel Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Bloomston, MD Ohio State University
PRS Account Candel Therapeutics, Inc.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP