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Phase I Study Combining Replication-Competent Adenovirus-Mediated Suicide Gene Therapy With Chemoradiotherapy for the Treatment of Non-Metastatic Pancreatic Adenocarcinoma

Phase 1
18 Years
80 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Phase I Study Combining Replication-Competent Adenovirus-Mediated Suicide Gene Therapy With Chemoradiotherapy for the Treatment of Non-Metastatic Pancreatic Adenocarcinoma

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.

Inclusion Criteria:

- Age > = 18 and < = 80.

- Non-metastatic, 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 0 - 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.

- Absolute WBC > 4,000/μL.

- Hemoglobin > 9.0 g/dL.

- 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

- 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

- 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).

- Active HIV disease.

- 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

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:

12 weeks post adenovirus injection

Safety Issue:


Principal Investigator

Munther Ajlouni, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Henry Ford Health System


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Suicide



Henry Ford Health SystemDetroit, Michigan  48202