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Dendritic Cell Based Therapy of Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00197860
First received: September 12, 2005
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Renal Cell Carcinoma.A Phase I/II Study.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Primary aim of the study is to evaluate tolerability and safety of the treatment. [ Time Frame: weekly for the first four weeks, thereafter biweekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary aims: evaluation of treatment induced immune response and clinical response. [ Time Frame: after 8 and 16 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2004
Study Completion Date: October 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: tumor antigen loaded autologous dendritic cells
    DC vaccination regime consists of primary 10 intradermal injections of 1-2 weeks interval (q1w x 4 → q2w x 6). HLA-A2 positive patients are treated with survivin and telomerase peptide-pulsed dendritic cells, and HLA-A2 negative patients are treated with allogeneic tumor lysate-pulsed dendritic cells i.d. 1,6 mg Thymosin alpha 1 (Zadaxin®, SciClone) is administered s.c. twice a week and from the 2nd vaccine, 2 MIU Interleukin-2 is administered s.c. on day 2-6.
Detailed Description:

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
Criteria

Inclusion Criteria:

  • Histologically proven progressive metastatic or locally advanced renal cell carcinoma
  • No standard treatment indicated
  • Age: > 18
  • WHO-Performance Status 0-1
  • At least tone measurable tumor lesions according to the RECIST criteria.
  • Life expectancy more than 3 months
  • Acceptable CBC and blood chemistry results
  • Written informed consent

Exclusion Criteria:

  • Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
  • Patients with metastatic disease in the central nervous system (CNS).
  • Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
  • Patients with acute or chronic infection including HIV, hepatitis and tuberculosis.
  • Patients who are pregnant.
  • Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
  • Patients who receive corticosteroids or other immunosuppressive agents.
  • Baseline serum LDH greater than 4 times the upper limit of normal.
  • Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197860

Locations
Denmark
Department of Oncology, Copenhagen University Hospital, Herlev
Herlev, Denmark, 2730
Sponsors and Collaborators
Inge Marie Svane
Investigators
Principal Investigator: Inge Marie Svane, MD, PHD Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
  More Information

Publications:

Responsible Party: Inge Marie Svane, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00197860     History of Changes
Other Study ID Numbers: UR0414
Study First Received: September 12, 2005
Last Updated: November 22, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Herlev Hospital:
dendritic cell
vaccine
renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 16, 2012