Dendritic Cell-based Immunotherapy in Mesothelioma

NCT00280982 | Completed Phase 1

• 2 other identifiers: MEC-2005-269PMR-MM05-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Mesothelioma

Keywords

dendritic cells, immunotherapy, vaccination, mesothelioma

Outcome Measures

Primary Outcomes (2)

• safety

  april 2008

• tolerability

  april 2008

Interventions

tumor lysate-loaded autologous dendritic cells BIOLOGICAL

50x10e6 cells per vaccination, 3 times, 2 weeks interval

Also known as: DC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Department of Pulmonary Medicine

Rotterdam, South Holland, 3015 GE, Netherlands

Location

Related Publications (2)

• Hegmans JP, Hemmes A, Aerts JG, Hoogsteden HC, Lambrecht BN. Immunotherapy of murine malignant mesothelioma using tumor lysate-pulsed dendritic cells. Am J Respir Crit Care Med. 2005 May 15;171(10):1168-77. doi: 10.1164/rccm.200501-057OC. Epub 2005 Mar 11.

  PMID: 15764728 BACKGROUND

• Hegmans JP, Veltman JD, Lambers ME, de Vries IJ, Figdor CG, Hendriks RW, Hoogsteden HC, Lambrecht BN, Aerts JG. Consolidative dendritic cell-based immunotherapy elicits cytotoxicity against malignant mesothelioma. Am J Respir Crit Care Med. 2010 Jun 15;181(12):1383-90. doi: 10.1164/rccm.200909-1465OC. Epub 2010 Feb 18.

  PMID: 20167848 DERIVED

MeSH Terms

Conditions

Mesothelioma, Malignant; Mesothelioma

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Joachim G Aerts, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 20, 2006
• First Posted: January 24, 2006
• Study Start: January 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 16, 2010

Record last verified: 2010-11

Locations

NL (1)