Condition category
Cancer
Date applied
08/03/2006
Date assigned
08/03/2006
Last edited
14/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J. Hegmans

ORCID ID

Contact details

Erasmus Medical Center
Department of Pulmonary Medicine
Dr. Molewaterplein 50
Rotterdam
3015 GE
Netherlands
+31 (0)10 4087703
j.hegmans@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00280982

Protocol/serial number

NTR600; MEC-2005-269

Study information

Scientific title

Acronym

DC-immunotherapy

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

Ethics approval

Received from local medical ethics committee

Study design

Non-randomised open label uncontrolled single group assignment phase I efficacy study

Primary study design

Interventional

Secondary study design

Other

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Malignant mesothelioma

Intervention

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

Intervention type

Other

Phase

Phase I

Drug names

Primary outcome measures

1. Safety
2. Tolerability

Secondary outcome measures

1. Anti-tumor responses in vitro and in vivo
2. Clinical response evaluation

Overall trial start date

01/01/2006

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant 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.

Recruitment start date

01/01/2006

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3015 GE
Netherlands

Sponsor information

Organisation

Erasmus Medical Center, Department of Pulmonary Medicine (The Netherlands)

Sponsor details

Dr Molewaterplein 50
Rotterdam
3015 GE
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Mesothelioma Applied Research Foundation (MARF) (USA)

Alternative name(s)

Mesothelioma Applied Research Foundation, Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Funder name

Asbestos Cancer Foundation (Stichting Asbestkanker) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes