A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma
This study has suspended participant recruitment.
(Closed to Accrual)
Sponsor:
University of Michigan Cancer Center
Information provided by (Responsible Party):
Mark Zalupski, M.D., University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00843830
First received: February 12, 2009
Last updated: July 24, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Pancreatic Carcinoma |
Radiation: tumoral irradiation Biological: Dendritic cell vaccination Biological: Additional cycles |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by University of Michigan Cancer Center:
Primary Outcome Measures:
- To evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
- To evaluate the anti-tumor response as determined by RECIST criteria [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 6 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment Arm |
Radiation: 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)
Biological: 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.
Biological: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 > 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 < 15, INR < 1.5 and PTT < 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, 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843830
Locations
| United States, Michigan | |
| Universtiy of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
| Principal Investigator: | Mark M. Zalupski, M.D. | Universtiy of Michigan Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | Mark Zalupski, M.D., Professor, Department of Internal Medicine, University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00843830 History of Changes |
| Other Study ID Numbers: | UMCC 2005.135 |
| Study First Received: | February 12, 2009 |
| Last Updated: | July 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Pancreatic Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms |
Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013