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| Sponsors and Collaborators: |
University of Michigan Cancer Center University of Michigan |
| Information provided by: | University of Michigan Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00176761 |
Purpose
This study is being conducted to determine the efficacy, side effects, and toxicity of an investigational vaccine that consists of tumor-pulsed dendritic cells administered with an immune stimulating drug called interleukin-2 (IL-2). Dendritic cells are immune cells that are obtained from a subject's blood and are important in the body’s immune response to foreign substances. This study will examine the response of a subject's immune system after receiving several vaccinations containing their own dendritic cells which have been exposed to dead fragments of their cancer cells in the laboratory. This may result in sensitizing a subject's dendritic cells to their cancer cells so that their dendritic cells will react with other cells of the immune system and attack the cancer. It has been shown in the laboratory that dendritic cells exposed to cancer cell fragments can provide lymphocytes (a type of white blood cell) with signals they require in order to become fully activated and acquire the ability to kill cancer cells.
| Condition | Intervention | Phase |
|
Metastatic Colorectal Cancer |
Drug: Interleukin-2 (IL-2) |
Phase II |
| MedlinePlus related topics: | Cancer Colorectal Cancer |
| ChemIDplus related topics: | Interleukin-2 |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | A Phase II Trial Assessing Autologous, Tumor-Pulsed Dendritic Cells as a Tumor Vaccine Administered With IL-2 in Patients With Metastatic Colorectal Cancer |
| Estimated Enrollment: | 27 |
| Study Start Date: | March 2000 |
| Estimated Study Completion Date: | May 2006 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate baseline hematopoietic function:
Exclusion Criteria
Contacts and Locations| United States, Michigan | |||||
| University of Michigan Cancer Center | |||||
| Ann Arbor, Michigan, United States, 48109 | |||||
| University of Michigan Cancer Center |
| University of Michigan |
| Principal Investigator: | Mark Zalupski, M.D. | University of Michigan Cancer Center |
More Information
| Study ID Numbers: | UMCC 9947, GCRC Protocol #1673 |
| First Received: | September 9, 2005 |
| Last Updated: | September 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00176761 |
| Health Authority: | United States: Food and Drug Administration; United States: University of Michigan Data Safety Monitoring Board; United States: University of Michigan Quality Assurance Review Committee |
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