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

Information source: Advantagene, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Adenocarcinoma; Pancreatic Cancer

Intervention: AdV-tk (Biological); Valacyclovir (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Advantagene, Inc.

Official(s) and/or principal investigator(s):
Mark Bloomston, MD, Principal Investigator, Affiliation: Ohio State University

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

Overall survival

Progression free survival

Tumor response including pathologic response

Quality of life

Resectability

CA 19-9 response

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

City of Hope Medical Center, Duarte, California 91010, United States

Scripps Green Hospital/Scripps Cancer Center, La Jolla, California 92037, United States

The Ohio State University, Columbus, Ohio 43210, United States

Additional Information

Starting date: August 2008
Last updated: February 24, 2015

Page last updated: August 23, 2015

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