Metastatic Pancreatic Carcinoma Clinical Trial
This study is being done to determine whether it is possible to use an investigational
vaccine that consists of dendritic cells in patients with pancreas cancer. Dendritic cells
are immune cells that are obtained from your blood that are important in the body's immune
response to foreign substances. The vaccine would be injected directly into a tumor that has
spread to the liver after a short course of radiation therapy has been given to that tumor.
The study will try to determine if this treatment would be safe and effective in treating
this cancer.
This is a phase 1 pilot study of this treatment. Phase 1 trials test the best way to give a
treatment where little is known about its possible risks or benefits. Phase 2 studies then
test the possible benefits of a treatment and may show the specific situations where they
are seen. Promising treatments are then tested in Phase 3 trials which compare the new
treatment to standard treatment in a larger group of patients. Phase 4 trials are those
conducted on a treatment after it has been approved for general use outside of research. A
pilot study tests a treatment in a small number of patients to learn if and how the
treatment could be tested in a larger group. Pilot studies can be performed at any phase but
are commonly performed in the earliest phases of research on a treatment.
Status | Terminated |
Enrollment | 4 |
Est. completion date | April 2010 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Pathologic diagnosis of pancreatic carcinoma - Radiologic evidence of hepatic metastasis with at least one lesion > 2.0 cm that is amenable to ultrasound or CT guided intra-tumoral DC injection - Age > 18 - Life expectancy > 3 months - Karnofsky Performance Status > 70% - Patients must not have received any anti-neoplastic chemotherapy, immunotherapy or radiotherapy for the four weeks preceding entry onto the study (six weeks for nitrosoureas and mitomycin C). - Adequate baseline hematopoietic function defined as WBC (white blood cell) > 3000/mm3, hemoglobin > 9g/dl, and platelet count > 100,000/mm3. - Adequate baseline organ function defined as creatinine < 2.0, total bilirubin < 2.0 mg/dl - Patients taking warfarin are not eligible. Adequate coagulation function defined as PT (prothrombin time) < 15, INR < 1.5 and PTT (partial thromboplastin time) < 35. - Ability to give informed consent Exclusion Criteria: - Previous anti-tumor vaccine therapy - Prior hepatic irradiation - Known brain metastases - History of prior autoimmune diseases (e.g. SLE (systemic lupus erythematosus), rheumatoid arthritis, myasthenia gravis) - Regular corticosteroid use within the past one year or any corticosteroid use in the four weeks preceding study entry - Evidence of HIV infection, AIDS, Hepatitis B or Hepatitis C infection - Active bacterial, fungal or viral infection - Pregnancy or lactation; women of childbearing potential and men must agree to use effective contraception during the course of this clinical trial - Uncontrolled or unstable medical conditions including angina, arrhythmias, bleeding, or thromboembolic conditions, - Any medical or psychiatric illness that might compromise the patients ability to tolerate treatment |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Universtiy of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination. | The primary objective of this study was to evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. The treatment will be deemed feasible if 80% or more patients complete radiation therapy, all three vaccinations, and evaluation for tumor response four weeks after the third vaccination. | 10 weeks | Yes |
Secondary | Number of Patients That Respond to Treatment | To evaluate the anti-tumor response as determined by RECIST criteria | 10 weeks | No |
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