Status:
TERMINATED
A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Metastatic Pancreatic Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00843830
Start Date
October 1 2006
End Date
April 1 2010
Last Update
December 8 2015
Active Locations (1)
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1
Universtiy of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109