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Sponsored by: |
University of Pittsburgh |
Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00558051 |
The purpose of this study is to evaluate the administration, safety and immunologic effectiveness of an experimental vaccine for colorectal cancer patients.
Condition | Intervention | Phase |
Metastatic Colorectal Cancer |
Biological: DC-based vaccine |
Phase I |
MedlinePlus related topics: | Cancer Colorectal Cancer |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase I Evaluation of Semi-Continuous Alpha-Type-1 Dendritic Cell-Based Vaccines in Patients With Metastatic Colorectal Cancer |
Estimated Enrollment: | 9 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Active Comparator
Intradermal administration
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Biological: DC-based vaccine
Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of 4 intradermal injections once a day for 4 days.
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B: Active Comparator
Intranodal administration
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Biological: DC-based vaccine
Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of 1 intranodal injection.
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C: Active Comparator
Intralymphatic infusion
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Biological: DC-based vaccine
Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of a 4-day intralymphatic infusion.
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Dendritic cell (DC)-based vaccination, usually administered by a traditional intradermal route, is a new treatment option for cancer patients. While the previous DC-based vaccination trials have shown the safety of this approach and its ability to induce objective clinical responses, the overall efficacy of DC-based vaccines is still disappointing (Rosenberg et al., 2004). We hypothesize that the two likely causes of such limited clinical activity are: A) suboptimal type of DCs used as a vaccine and B) suboptimal modes of use of such vaccines that do not allow the vaccinated patients to fully benefit from DC biology.
We will conduct a pilot evaluation of the therapeutic vaccination with DC1s loaded with autologous tumor material, in patients with metastatic colorectal cancer that have been resected to no or minimal evidence of disease.The proposed evaluation of the novel intralymphatic route of DC-based vaccination will allow us to administer the vaccine in a way that is more physiologic with respect to the kinetics of antigen appearance to the lymph nodes and is feasible to be performed in repetitive fashion, without damaging local lymph nodes.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David L. Bartlett, MD | 412-692-2520 | bartlettdl@upmc.edu |
Contact: Amy R. Schmotzer, RN, BSN | (412) 647-6205 | schmotzerar@upmc.edu |
United States, Pennsylvania | |||||
University of Cancer Institute | Recruiting | ||||
Pittsburgh, Pennsylvania, United States, 15232 | |||||
Contact: David L. Bartlett, MD 412-692-2852 bartlettdl@upmc.edu | |||||
Contact: Amy R. Schmotzer, RN, BSN (412) 647-6205 schmotzerar@upmc.edu | |||||
Principal Investigator: David L. Bartlett, MD |
University of Pittsburgh |
Principal Investigator: | David L. Bartlett, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh Cancer Institute ( David Bartlett, MD ) |
Study ID Numbers: | 05-063 |
First Received: | November 13, 2007 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00558051 |
Health Authority: | United States: Food and Drug Administration |
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