A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Michigan Rogel Cancer Center
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Ability to give informed consent
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
Clareo Health | A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma