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Vaccination With Autologous Dendritic Cells Pulsed With Tumor Lysate for Treatment of Patients With Malignant Pleural Mesothelioma

Phase 1
18 Years
Not Enrolling
Malignant Pleural Mesothelioma

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Trial Information

Vaccination With Autologous Dendritic Cells Pulsed With Tumor Lysate for Treatment of Patients With Malignant Pleural Mesothelioma

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.

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

- 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

- 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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

april 2008

Safety Issue:


Principal Investigator

Joachim G Aerts, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Erasmus Medical Center


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

January 2006

Completion Date:

September 2009

Related Keywords:

  • Malignant Pleural Mesothelioma
  • dendritic cells, immunotherapy, vaccination, mesothelioma
  • Mesothelioma