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Dendritic Cell-based Immunotherapy in Mesothelioma

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ClinicalTrials.gov Identifier: NCT00280982
Recruitment Status : Completed
First Posted : January 24, 2006
Last Update Posted : November 16, 2010
Sponsor:
Information provided by:
Erasmus Medical Center

Tracking Information
First Submitted Date  ICMJE January 20, 2006
First Posted Date  ICMJE January 24, 2006
Last Update Posted Date November 16, 2010
Study Start Date  ICMJE January 2006
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2008)
  • safety [ Time Frame: april 2008 ]
  • tolerability [ Time Frame: april 2008 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2006)
  • safety
  • tolerability
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2006)
  • anti-tumor responses in vitro and in vivo
  • clinical response evaluation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dendritic Cell-based Immunotherapy in Mesothelioma
Official Title  ICMJE Vaccination With Autologous Dendritic Cells Pulsed With Tumor Lysate for Treatment of Patients With Malignant Pleural Mesothelioma
Brief Summary Exploiting the immunostimulatory capacities of dendritic cells holds great promise for cancer immunotherapy. A mouse model for malignant mesothelioma allowed us to prove that autologous dendritic cells presenting tumor antigens were very effective by (partly) inhibiting tumor growth. This study will test the feasibility and safety of a clinical trial using autologous DC as a therapeutic adjuvant for the treatment of malignant pleural mesothelioma.
Detailed Description

For this phase I study, patients with end-stage malignant mesothelioma and who are deemed to be fit enough to be treated with chemotherapy will be asked to participate in this study. Patients will first be treated with 4 courses of chemotherapy (standard treatment[Alimta/cisplatin]). After this chemotherapy a leukapherese is performed of which the monocytes are used for differentiation to dendritic cells. The procedure to grow these dendritic cells in vitro (culture) and pulse them with tumor lysate is performed in a cleanroom environment. Several quality control tests will be performed before the dendritic cells are ready for re-injection. Three doses of properly pulsed autologous dendritic cells are then re-injected every two weeks.

Using the proper procedure in mesothelioma patients, minor side effects are expected.

Ten (10) patients will be treated by this procedure to define the safety and toxicity of immunization and to observe (anti-tumor) immune responses.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Pleural Mesothelioma
Intervention  ICMJE Biological: tumor lysate-loaded autologous dendritic cells
50x10e6 cells per vaccination, 3 times, 2 weeks interval
Other Name: DC
Study Arms  ICMJE Not Provided
Publications *

*   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: January 20, 2006)
10
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with clinically and histological or cytological confirmed newly diagnosed mesothelioma, that can be measured in two dimensions by a radiologic imaging study.
  • Patients must be at least 18 years old and must be able to give written informed consent.
  • Patients must be ambulatory (Karnofsky scale > 70, or WHO-ECOG performance status 0,1, or 2) and in stable medical condition. The expected survival must be at least 4 months.
  • Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count > 1.5*109/l, platelet count > 100*109/l, and Hb > 6.0 mmol/l.
  • Positive delayed type hypersensitivity skin test (induration > 2mm after 48hrs) against at least one positive control antigen of MULTITEST CMI (Pasteur merieux).
  • Stable disease or response after chemotherapy.
  • Availability of sufficient tumor material of the patient.
  • Ability to return to the Erasmus MC for adequate follow-up as required by this protocol.

Exclusion Criteria:

  • Conditions that make the patient unfit for chemotherapy or progressive disease after 4 cycles of chemotherapy.
  • Pleurodesis at the affected side before the pleural fluid is obtained.
  • Medical or psychological impediment to probable compliance with the protocol.
  • Patients on steroid (or other immunosuppressive agents) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation and must stop of any such treatment during the time of the study.
  • No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the patient has been disease-free for five years.
  • Serious concomitant disease, no active infections. Patients with a history of autoimmune disease or organ allografts, or with active acute or chronic infection, including HIV and viral hepatitis.
  • Patients with serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinators to constitute an unwarranted high risk for investigational DC treatment.
  • Patients with a known allergy to shell fish (contains KLH).
  • Pregnant or lactating women.
  • Patients with inadequate peripheral vein access to perform leukapheresis
  • Concomitant participation in another clinical trial
  • An organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent, and preclude participation in the full protocol and follow-up.
  • Absence of assurance of compliance with the protocol. Lack of availability for follow-up assessment.
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 Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00280982
Other Study ID Numbers  ICMJE MEC-2005-269
PMR-MM05-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erasmus MC, Pulmonary Medicine
Study Sponsor  ICMJE Erasmus Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joachim G Aerts, MD, PhD Erasmus Medical Center
PRS Account Erasmus Medical Center
Verification Date November 2010

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