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Phase I Study Combining Suicide Gene Therapy With Chemoradiotherapy in the Treatment of Non-Metastatic Pancreatic Adenocarcinoma
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
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| Phase I | Biomarker/Laboratory analysis, Treatment | Active | 18 to 80 | Panc4242
P01 CA097012, NCT00415454 |
Trial Description
Summary 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 Further Study Information 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). Eligibility Criteria Inclusion Criteria: - Non-metastatic, localized pancreatic cancer including resectable, potentially resectable, and unresectable tumors
- No evidence of peritoneal and/or hematogenous metastasis.
- Histologically proven (biopsy or cytology) adenocarcinoma.
- No evidence of peritoneal and/or hematogenous metastasis.
- No prior chemotherapy, radiotherapy or biological therapy.
- ECOG Performance status better than or equal to 2.
- Subjects must have adequate baseline organ function, as assessed by the following laboratory values, within 30 days before initiating the study therapy:
- Adequate renal function with serum creatinine <=1.5 mg/dL or creatinine clearance >=50 mL/min/m2.
- Platelet count > 100,000/μL.
- Bilirubin < 1.5 mg/dL; SGOT and SGPT < 2.5 times upper limit of normal (ULN).
- No history of malignancy within 5 years except for non-melanomatous skin cancer or carcinoma in situ of the cervix.
- Men and women with conceptive potential must agree to follow a medically acceptable method of birth control.
- Patients on oral warfarin anticoagulation therapy may be included in this study, but must have close monitoring of their coagulation parameters as altered parameters and/or bleeding have been reported in patients taking Xeloda® and such agents concomitantly.
- The subject must possess the ability to give informed consent and express a willingness to meet all of the expected requirements of the protocol for the duration of the study.
Exclusion Criteria: - Pregnant and lactating women.
- Serious non-malignant disease (e.g., congestive heart failure or uncontrolled infections), which, in the opinion of the investigator would compromise study objectives.
- Major surgery within four weeks other than diagnostic procedures such as laparoscopy, endoscopic ultrasound and stenting or PEG/PEJ placement.
- Islet cell tumor, benign cyst, peri-ampullary carcinoma or any non-adenocarcinomas.
- Acute infection. Acute infection is defined by any viral, bacterial, or fungal infection that has required specific therapy within 72 hours of initiation of the study therapy (defined as Day 1).
- Previous history of liver disease including hepatitis.
- Positive serologic test for Hepatitis B or C at baseline.
- Immunosuppressive therapy including systemic corticosteroids. Use of inhaled and topical corticosteroids is permitted.
- Serious medical or psychiatric illness or concomitant medication, which, in the judgment of the investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial.
- Impaired immunity or susceptibility to serious viral infections.
- Allergy to any product used on the protocol including ciprofloxacin.
- Clinical or laboratory evidence of pancreatitis
Trial Contact Information
Trial Lead Organizations/Sponsors Josephine Ford Cancer Center at Henry Ford Hospital | Munther Ajlouni, M.D. | | Principal Investigator |
Trial Sites
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| U.S.A. |
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| Michigan |
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Detroit |
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| | | | | | | | | Josephine Ford Cancer Center at Henry Ford Hospital |
| | | Jan Pegg, RN |
Ph: 313-916-3938 |
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Email:
jpegg1@hfhs.org |
| | | Munther Ajlouni, M.D. | Principal Investigator |
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See All Trial Sites
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00415454
Information obtained from ClinicalTrials.gov on May 13, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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