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Sponsored by: |
Henry Ford Health System |
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Information provided by: | Henry Ford Health System |
ClinicalTrials.gov Identifier: | NCT00415454 |
The primary purpose of this Phase I study is to determine the safety of combining replication-competent adenovirus-mediated suicide gene therapy with chemoradiotherapy in patients with non-metastatic pancreatic cancer
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Genetic: ad5-yCD/mutTKSR39rep-ADP |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase I Study Combining Replication-Competent Adenovirus-Mediated Suicide Gene Therapy With Chemoradiotherapy for the Treatment of Non-Metastatic Pancreatic Adenocarcinoma |
Estimated Enrollment: | 15 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
The objectives of this study are:
To determine the toxicity and maximum tolerated dose (MTD) of the Ad5-yCD/mutTKSR39rep-ADP adenovirus in combination with 5-fluorocytosine (5-FC) and valganciclovir (vGCV) prodrug therapy and neoadjuvant chemoradiotherapy. Fifteen to 30 subjects (5 cohorts of 3 - 6 subjects each) with potentially resectable pancreatic cancer will receive a single intratumoral injection of the Ad5-yCD/mutTKSR39rep-ADP adenovirus at one of five dose levels (1 x 1010, 3 x 1010, 1 x 1011, 3 x 1011, 1 x 1012 vp) under endoscopic ultrasound (EUS)-guidance. Beginning three days later, subjects will receive 3 weeks (15 days) of 5-FC and vGCV prodrug therapy concomitant with a 5.6 week (28 day) course of capecitabine chemotherapy and 50.4 Gy conformal radiotherapy. Within two weeks after completion of the chemoradiation course, subjects will be re-staged and will undergo surgery if the primary tumor is deemed resectable.
The primary endpoint is toxicity at 6 weeks. Secondary endpoints are: 1) toxicity at 3 months, 2) tumor (radiological) response, 3) time to disease progression, 4) survival, 5) histopathological evidence of tumor destruction, 6) immunohistochemical evidence of adenoviral replication, 7) persistence of Ad5-yCD/mutTKSR39rep-ADP adenoviral DNA in blood, and 8) evidence of therapeutic gene expression in vivo as determined by positron emission tomography (PET).
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jan Pegg, RN | 313.916-3938 | jpegg1@hfhs.org |
United States, Michigan | |
Henry Ford Health System | Recruiting |
Detroit, Michigan, United States, 48202 | |
Contact: Jan Pegg, RN 313-916-3938 jpegg1@hfhs.org | |
Principal Investigator: Munther Ajlouni, M.D. |
Principal Investigator: | Munther Ajlouni, M.D. | Henry Ford Health System |
Responsible Party: | Henry Ford Health System ( Svend O. Freytag, Ph.D. ) |
Study ID Numbers: | Panc4242, P01 CA097012 |
Study First Received: | December 21, 2006 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00415454 |
Health Authority: | United States: Food and Drug Administration |
Pancreatic Cancer |
Digestive System Neoplasms Adenoviridae Infections Pancreatic Neoplasms Suicide Endocrine System Diseases Carcinoma Digestive System Diseases |
Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |