Metastatic Pancreatic Carcinoma
Conditions
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.
Interventions
RADIATIONtumoral irradiation
On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
BIOLOGICALDendritic cell vaccination
Three intra-tumoral injections of 1 ml cell suspensions of KLH (keyhole limpet hemocyanin)- pulsed DC (dendritic cells) will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination. | 10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients That Respond to Treatment | 10 weeks | To evaluate the anti-tumor response as determined by RECIST criteria |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 61 years |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 4 |
| serious Total, serious adverse events | 1 / 4 |
Outcome results
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.
Time frame: 10 weeks
Population: The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct.
Secondary
Number of Patients That Respond to Treatment
To evaluate the anti-tumor response as determined by RECIST criteria
Time frame: 10 weeks
Population: The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct.