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Dendritic cell-based immunotherapy in mesothelioma.


- candidate number1972
- NTR NumberNTR600
- ISRCTNISRCTN66517336
- Date ISRCTN created8-mrt-2006
- date ISRCTN requested7-mrt-2006
- Date Registered NTR7-feb-2006
- Secondary IDsMEC-2005-269 
- Public TitleDendritic cell-based immunotherapy in mesothelioma.
- Scientific TitleDendritic cell-based immunotherapy in patients with malignant pleural mesothelioma (MM).
- ACRONYMDC-immunotherapy
- hypothesisBased on studies in other types of cancer in humans where beneficial effects were obtained, and based on our pre-clinical data in a mouse model for malignant mesothelioma (MM), it now seems feasible and warranted to introduce dendritic cell (DC)-immunotherapy for human mesothelioma. It can be expected that using the proper procedure in mesothelioma patients, a beneficial effect of immunotherapy can be obtained without major side effects. The objectives of this phase I study are: 1. To define the safety and toxicity of tumor lysate-pulsed DCs injected in patients with mesothelioma; 2. To determine if vaccination with tumor lysate-pulsed DCs results in a detectable immune response by skin delayed type hypersensitivity (DTH) reactions on mesothelioma crude antigen and KLH and by in vitro laboratory analysis. - To observe and document anti-cancer activity by clinival evaluation.
- Healt Condition(s) or Problem(s) studiedMesothelioma
- Inclusion criteria1. Patients with clinically and histological or cytological confirmed newly diagnosed mesothelioma, that can be measured in two dimensions by a radiologic imaging study; 2. Patients must be at least 18 years old and must be able to give written informed consent; 3. 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; 4. 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; 5. Positive DTH skin test (induration > 2mm after 48hrs) against at least one positive control antigen of MULTITEST CMI (Pasteur merieux); 6. Stable disease or response after chemotherapy; 7. Availability of sufficient tumor material of the patient; 8. Ability to return to the Erasmus MC for adequate follow-up as required by this protocol.
- Exclusion criteria1. Conditions that make the patient unfit for chemotherapy or progressive disease after 4 cycles of chemotherapy; 2. Pleurodesis at the affected side before the pleural fluid is obtained; 3. Medical or psychological impediment to probable compliance with the protocol; 4. 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; 5. 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; 6. 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 (as determined by ELISA and confirmed by Western Blot) and viral hepatitis (as determined by HBsAg and Hepatitis C serology); 7.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; 8. Patients with a known allergy to shell fish (contains KLH); 9. Pregnant or lactating women; 10. Patients with inadequate peripheral vein access to perform leukapheresis; 11. Concomitant participation in another clinical trial; 12. 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; 13. Absence of assurance of compliance with the protocol. Lack of availability for follow-up assessment.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type-
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate31-dec-2008
- Target number of participants10
- InterventionsFormulation: autologous monocyte-derived dendritic cells (DCs) pulsed with autologous tumor lysate, Dose: > 5x10e6 DCs, Route of administration: 1/3 intraveneously and 2/3 intradermally Number of doses: 3 Schedule of doses: every 2 weeks
- Primary outcome1. Safety; 2. Tolerability.
- Secondary outcome1. Anti-tumor responses in vitro and in vivo; 2. Clinical response evaluation.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J. Hegmans
- CONTACT for SCIENTIFIC QUERIESDr. J. Aerts
- Sponsor/Initiator Erasmus Medical Center, Department of Pulmonary Medicine
- Funding
(Source(s) of Monetary or Material Support)
Mesothelioma Applied Research Foundation (MARF) , Stichting Asbestkanker
- PublicationsImmunotherapy of murine malignant mesothelioma using tumor lysate-pulsed dendritic cells http://ajrccm.atsjournals.org/cgi/reprint/171/10/1168 Am J Respir Crit Care Med Vol 171, pp 1168 1177 2005.
- Brief summaryDendritic cells are extremely potent antigen presenting cells and vital in inducing activation and proliferation of CD8+ cytotoxic T-lymphocytes. Exploiting the immunostimulatory capacities of these cells holds great promise for cancer immunotherapy. Based on studies in other types of cancer in humans where beneficial effects were obtained, and based on our pre-clinical data in a mouse model for malignant mesothelioma, it now seems feasible and warranted to introduce dendritic cell based-immunotherapy for mesothelioma patients. This study will test the feasibility and safety of a clinical trial using autologous dendritic cells as a therapeutic adjuvant for the treatment of mesothelioma. It can be expected that using the proper procedure in mesothelioma patients, a beneficial effect of immunotherapy can be obtained without major side effects.
- Main changes (audit trail)
- RECORD7-feb-2006 - 10-mrt-2006


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