Basic Trial Information

Phase: Phase I
Type: Treatment
Status: Active
Age: 18 and over
Sponsor: Erasmus Medical Center
Protocol IDs: MEC-2005-269; PMR-MM05-001, NCT00280982

Trial Description

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.

Eligibility Criteria

Inclusion 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.