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| Sponsor: | Herlev Hospital |
|---|---|
| Information provided by: | Herlev Hospital |
| ClinicalTrials.gov Identifier: | NCT00197860 |
Purpose
The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines can induce a measurable immune response in patients with metastatic renal cell carcinoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Renal Cell Carcinoma |
Biological: tumor antigen loaded autologous dendritic cells |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Renal Cell Carcinoma.A Phase I/II Study. |
| Estimated Enrollment: | 25 |
| Study Start Date: | September 2004 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived mature dendritic cells with a fixed interval. The dendritic cells are generated from leukapheresis products and frozen after antigen loading.
HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; survivin and telomerase peptides. HLA A2 negative patients are treated with KLH and tumorlysate pulsed DC; autologous or allogeneic. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by intradermal injection near the inguinal region. IL-2 2 MIU s.c. day 2-6 and Thymosin alpha 1 (Zadaxin®, SciClone) 1,6 mg s.c. twice a week are used for adjuvants. Scans and re-staging tests are performed at scheduled intervals throughout the study.
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| Contact: Inge Marie Svane, MD, PHD | +45 44 88 44 ext 82 131 | imsv@heh.regionh.dk |
| Denmark | |
| Department of Oncology, Copenhagen University Hospital, Herlev | Recruiting |
| Herlev, Denmark, 2730 | |
| Contact: Inge Marie Svane, MD,PHD +45 44 88 44 88 ext 82 131 imsv@heh.regionh.dk | |
| Sub-Investigator: Poul Geertsen, MD. PHD | |
| Sub-Investigator: Eva Ellebæk, MD | |
| Principal Investigator: | Inge Marie Svane, MD, PHD | Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark |
More Information
| Responsible Party: | Department of Oncology, Herlev Hospital ( Inge Marie Svane, MD, PhD, ) |
| Study ID Numbers: | UR0414 |
| Study First Received: | September 12, 2005 |
| Last Updated: | July 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00197860 History of Changes |
| Health Authority: | Denmark: Danish Medicines Agency |
|
dendritic cell vaccine renal cell carcinoma |
|
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell |
Urogenital Neoplasms Kidney Diseases Urologic Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |