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Sponsored by: |
Advantagene, Inc. |
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Information provided by: | Advantagene, Inc. |
ClinicalTrials.gov Identifier: | NCT00638612 |
The purpose of this 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. 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.
Condition | Intervention | Phase |
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Pancreatic Adenocarcinoma Pancreatic Cancer |
Biological: AdV-tk Drug: Valacyclovir |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study |
Official Title: | AdV-tk + Valacyclovir Therapy in Combination With Surgery and Chemoradiation for Pancreas Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
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.
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B: Experimental
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.
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
City of Hope Medical Center | Recruiting |
Duarte, California, United States, 91010 | |
Contact: Vincent Chung, MD 626-471-9200 | |
Contact: Carol Rose 626-359-8111 ext 62845 crose@coh.org | |
Principal Investigator: Vincent Chung, MD | |
United States, Ohio | |
The Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Mark Bloomston, MD 866-627-7616 osu@emergingmed.com | |
Principal Investigator: Mark Bloomston, MD |
Responsible Party: | Advantagene, Inc. ( Dr. Laura Aguilar/ VP Clinical Research ) |
Study ID Numbers: | PaTK01, 1R43CA119847 |
Study First Received: | March 6, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00638612 |
Health Authority: | United States: Food and Drug Administration |
Immunotherapy Gene Therapy Cytotoxicity Tumor vaccine |
Radiation Surgery Chemoradiation |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Carcinoma Valacyclovir Digestive System Diseases |
Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Anti-Infective Agents Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Therapeutic Uses Antiviral Agents Pharmacologic Actions |