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| Sponsored by: |
Genzyme |
|---|---|
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00050323 |
Purpose
The primary purpose of this study is to determine the safety of injections prepared from donor blood cells fused to a patient's own tumor cells which are then used to treat advanced (Stage IV) kidney cancer (renal cell carcinoma or RCC). The study will also explore the effect the injections have on the size of the tumor and the response in the patient's immune system following administration.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Renal Cell |
Drug: Allogeneic DCs and Autologous RCC Tumor Derived Cells |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase 1/2 Study to Assess the Safety and Efficacy of Vaccinations With Allogeneic Dendritic Cells: Autologous Tumor-Derived Cells Subjected to Electrofusion in Patients With AJCC Stage IV Renal Cell Carcinoma |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2002 |
Approximately 30,000 new cases of kidney cancer will be diagnosed in the U.S. in 2002, with renal cell carcinoma (RCC) being the most commonly diagnosed type. For patients with locally advanced or metastatic disease, the treatment options are extremely limited and additional options are warranted.
Although RCC is generally considered resistant to chemotherapy, spontaneous regressions in patients with metastatic disease have led to research involving immune-mediated therapeutic approaches. Clinical responses have been observed and additional immune-modulating therapeutics are being studied.
Several such approaches have used dendritic cells (DCs), which are known to be potent antigen presenting cells. An antigen is a protein that, when shown to the immune system in the right way, can trigger the cells of the immune system to recognize, remember and eliminate other cells that also display that specific antigen. The cancerous cells in tumors present antigens in such a way that the body's immune system often fails to recognize and eliminate them. It is theorized that when DCs are fused to tumor cells the resulting fused cells will be capable of presenting tumor antigens in an enhanced manner, thus allowing the body's immune system to recognize the tumor antigens on the cancer itself. If this occurs, the patient's immune system may be specifically stimulated, producing a clinically meaningful immune response against the tumor.
In this study DCs produced from healthy volunteer donors (allogeneic DCs) will be fused to the patient's own tumor cells (autologous tumor cells), using an electrical current. The fused dendritic/tumor cells will be returned to the patient in a series of vaccines, six weeks apart.
The purpose of this trial is to determine whether fusing autologous tumor with allogeneic DCs will, with limited associated toxicity, present tumor antigen in such a way as to stimulate an immune response and also show evidence of tumor response.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Dana Farber Cancer Institute (DFCI) | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Ohio | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
More Information
| Study ID Numbers: | DCREN-005-01 |
| Study First Received: | December 4, 2002 |
| Last Updated: | August 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00050323 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Stage IV Renal Cell Carcinoma Kidney Cancer Cancer (General) |
|
Urinary Tract Neoplasm Kidney Cancer Renal Cancer Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell |
Urogenital Neoplasms Kidney Diseases Adenocarcinoma Urologic Neoplasms Neoplasms, Glandular and Epithelial Carcinoma |
|
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell |
Urogenital Neoplasms Kidney Diseases Adenocarcinoma Urologic Neoplasms Neoplasms, Glandular and Epithelial Carcinoma |