Back to results

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

Primary Purpose

Pancreatic Adenocarcinoma, Pancreatic Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AdV-tk

Valacyclovir

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring Immunotherapy, Gene Therapy, Cytotoxicity, Tumor vaccine, Radiation, Surgery, Chemoradiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

City of Hope Medical Center
Scripps Green Hospital/Scripps Cancer Center
The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

A resectable

B locally advanced

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of treatment emergent adverse events

Secondary Outcome Measures

Overall survival

Progression free survival

Tumor response including pathologic response

Functional Assessment of Cancer Therapy - Pancreas (FACT-Hep)

Full Information

NCT ID

NCT00638612

First Posted

March 6, 2008

Last Updated

August 23, 2023

Sponsor

Candel Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00638612

Brief Title

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

Acronym

PaTK01

Official Title

AdV-tk + Valacyclovir Therapy in Combination With Surgery and Chemoradiation for Pancreas Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Candel Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Adenocarcinoma, Pancreatic Cancer

Keywords

Immunotherapy, Gene Therapy, Cytotoxicity, Tumor vaccine, Radiation, Surgery, Chemoradiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A resectable

Arm Type

Experimental

Arm Description

Arm Title

B locally advanced

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

AdV-tk

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Valacyclovir

Other Intervention Name(s)

Valtrex

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of treatment emergent adverse events

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

2 years

Title

Progression free survival

Time Frame

2 years

Title

Tumor response including pathologic response

Time Frame

2 months

Title

Functional Assessment of Cancer Therapy - Pancreas (FACT-Hep)

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Bloomston, MD

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

City of Hope Medical Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Scripps Green Hospital/Scripps Cancer Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25795132

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs