NCT00415454

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

First QC Date

December 21, 2006

Last Update Submit

June 21, 2011

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Toxicity

    12 weeks post adenovirus injection

Secondary Outcomes (4)

  • Tumor response

    3 - 12 months

  • Time to progression

    3 - 12 months

  • Survival

    10 - 20 months

  • Gene expression in pancreas

    1 - 14 days

Study Arms (1)

Gene therapy

EXPERIMENTAL

Adenovirus injection followed by 3 weeks of 5-FC + vGCV prodrug therapy and a 6 week course of capecitabine-based chemoradiation

Genetic: Ad5-yCD/mutTKSR39rep-ADP

Interventions

Ad5-yCD/mutTKSR39rep-ADPGENETIC

Single injection on day 1 at one of five dose levels

Gene therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +2 more criteria

You may not qualify if:

  • 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).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Munther Ajlouni, M.D.

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 25, 2006

Study Start

November 1, 2006

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

US(1)