Phase I Study Combining Suicide Gene Therapy With Chemoradiotherapy in the Treatment of Non-Metastatic Pancreatic Adenocarcinoma
| Status: | Archived |
|---|---|
| Conditions: | Cancer, Cancer, Psychiatric, Pancreatic Cancer |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
Phase I Study Combining Replication-Competent Adenovirus-Mediated Suicide Gene Therapy With Chemoradiotherapy for the Treatment of Non-Metastatic Pancreatic Adenocarcinoma
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
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 standard chemoradiation. Fifteen to 30 subjects (5 cohorts of 3 - 6 subjects
each) with non-metastatic, unresectable pancreatic cancer will receive a single intratumoral
injection of the Ad5-yCD/mutTKSR39rep-ADP adenovirus at one of five dose levels (1 x 10e10
vp, 3 x 10e10 vp, 1 x 10e11 vp, 3 x 10e11 vp, 1 x 10e12 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 6 week (30 day) course of capecitabine
chemotherapy and 54 Gy conformal radiotherapy.
The primary endpoint is toxicity at 12 weeks. Secondary endpoints are: 1) tumor
(radiological) response, 2) time to disease progression, 3) survival, 4) persistence of
Ad5-yCD/mutTKSR39rep-ADP adenoviral DNA in blood, 5) infectious Ad5-yCD/mutTKSR39rep-ADP
adenovirus in blood, and 6) HSV-1 TK gene expression in the pancreas.
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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