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Dendritic Cell Based Therapy of Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00197860
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 23, 2011
Sponsor:
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date November 23, 2011
Study Start Date  ICMJE September 2004
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
Primary aim of the study is to evaluate tolerability and safety of the treatment. [ Time Frame: weekly for the first four weeks, thereafter biweekly ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Primary aim of the study is to evaluate tolerability and safety of the treatment.
Change History Complete list of historical versions of study NCT00197860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
Secondary aims: evaluation of treatment induced immune response and clinical response. [ Time Frame: after 8 and 16 weeks of treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Secondary aims: evaluation of treatment induced immune response and clinical response.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dendritic Cell Based Therapy of Renal Cell Carcinoma
Official Title  ICMJE Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Renal Cell Carcinoma.A Phase I/II Study.
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Renal Cell Carcinoma
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Svane IM, Pedersen AE, Johnsen HE, Nielsen D, Kamby C, Gaarsdal E, Nikolajsen K, Buus S, Claesson MH. Vaccination with p53-peptide-pulsed dendritic cells, of patients with advanced breast cancer: report from a phase I study. Cancer Immunol Immunother. 2004 Jul;53(7):633-41. Epub 2004 Feb 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2005)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00197860
Other Study ID Numbers  ICMJE UR0414
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Inge Marie Svane, Herlev Hospital
Study Sponsor  ICMJE Inge Marie Svane
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Inge Marie Svane, MD, PHD Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
PRS Account Herlev Hospital
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP