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22 May 2012
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| [ Print-friendly version ] |
| Dendritic cell-based immunotherapy in mesothelioma |
| ISRCTN | ISRCTN66517336 |
| ClinicalTrials.gov identifier | NCT00280982 |
| Public title | Dendritic cell-based immunotherapy in mesothelioma |
| Scientific title | |
| Acronym | DC-immunotherapy |
| Serial number at source | NTR600; MEC-2005-269 |
| Study hypothesis |
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 (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 3. To observe and document anti-cancer activity by clinical evaluation |
| Lay summary | |
| Ethics approval | Received from local medical ethics committee |
| Study design | Non-randomised open label uncontrolled single group assignment phase I efficacy study |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Malignant mesothelioma |
| Participants - inclusion criteria |
1. Patients with clinically and histologically or cytologically 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 World Health Organisation-Eastern Cooperative Oncology Group [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 x 10^9/l, platelet count >100 x 10^9/l, and Hb >6.0 mmol/l 5. Positive DTH skin test (induration >2 mm after 48 hours) 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 |
| Participants - exclusion criteria |
1. 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 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, active infections. Patients with a history of autoimmune disease or organ allografts, or with active acute or chronic infection, including human immunodeficiency virus (HIV) (as determined by enzyme-linked immunosorbent assay [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 chronic obstructive pulmonary disease [COPD]) or cardiac (New York Heart Association [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 keyhole limpet hemocyanin [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. |
| Anticipated start date | 01/01/2006 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 10 |
| Interventions |
Formulation: autologous monocyte-derived dendritic cells (DCs) pulsed with autologous tumor lysate
Dose: >5 x 10^6 DCs Route of administration: 1/3 intravenously and 2/3 intradermally Number of doses: 3 Schedule of doses: every 2 weeks |
| Primary outcome measure(s) |
1. Safety
2. Tolerability |
| Secondary outcome measure(s) |
1. Anti-tumor responses in vitro and in vivo
2. Clinical response evaluation |
| Sources of funding |
1. Mesothelioma Applied Research Foundation (MARF) (USA)
2. Asbestos Cancer Foundation (Stichting Asbestkanker) (Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Dr J. Hegmans |
| Address |
Erasmus Medical Center
Department of Pulmonary Medicine Dr. Molewaterplein 50 |
| City/town | Rotterdam |
| Zip/Postcode | 3015 GE |
| Country | Netherlands |
| Tel | +31 (0)10 4087703 |
| Fax | +31 (0)10 4089453 |
| j.hegmans@erasmusmc.nl | |
| Sponsor | Erasmus Medical Center, Department of Pulmonary Medicine (The Netherlands) |
| Address | Dr Molewaterplein 50 |
| City/town | Rotterdam |
| Zip/Postcode | 3015 GE |
| Country | Netherlands |
| Date applied | 08/03/2006 |
| Last edited | 14/08/2009 |
| Date ISRCTN assigned | 08/03/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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