Clinical trial NCT00843830: A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metastatic Pancreatic Carcinoma
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination.
timeFrame: 10 weeks
Secondary outcomes:
measure: Number of Patients That Respond to Treatment
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Universtiy of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: Universtiy of Michigan Comprehensive Cancer Center
name: Mark M. Zalupski, M.D.
role: PRINCIPAL_INVESTIGATOR
References: