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Clinical Trials/ISRCTN35881130
ISRCTN35881130
Completed
Not Applicable

Phase II/III, multicentre, open-label, randomised study comparing autologous intravesical macrophage cell therapy (Bexidem®) to intravesical Bacillus Calmette-Guerin (BCG) therapy in patients with superficial papillary bladder cancer who have undergone complete transurethral resection

IDM Pharma SA (France)0 sites650 target enrollmentMay 27, 2009
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
IDM Pharma SA (France)
Enrollment
650
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 27, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
IDM Pharma SA (France)

Eligibility Criteria

Inclusion Criteria

  • •1\. Male and female patients
  • •2\. At least 18 years of age
  • •3\. Fully resected papillary transitional cell carcinoma
  • •4\. Stage TaGI, TaGII, TaGIII, T1GI or T1GII (N0, M0\)
  • •5\. Either of the following:
  • •5\.1\. Plurifocal tumours
  • •5\.2\. Unifocal tumour provided greater than or equal to two tumour occurrences within the last 24 months
  • •6\. World Health Organization (WHO) performance status 0 \- 2
  • •7\. Normal upper urinary tract as documented by intravenous (IV) urography or computed tomography (CT) scan
  • •8\. Blood creatinine less than 200 umol/L

Exclusion Criteria

  • •1\. Greater than or equal to T1GIII bladder cancer
  • •2\. Carcinoma in situ (CIS)
  • •3\. Active tuberculosis
  • •4\. Other active infection (including urinary tract infection) and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV), human T\-lymphotropic virus (HTLV), hepatitis B or hepatitis C infection
  • •5\. History of other active malignancy within five years, except adequately treated basal cell and squamous cell carcinoma of the skin
  • •6\. Other serious illness or medical conditions (e.g. history of significant cardiac or respiratory dysfunction)
  • •7\. Patients with a contra\-indication preventing apheresis
  • •8\. History of autoimmune\-related disorder
  • •9\. Known hypersensitivity to any of the components of the study drugs (e.g. dimethylsulphoxide \[DMSO])
  • •10\. Immunosuppression or congenital or acquired immune deficiencies, whether due to concurrent disease (e.g. acquired immune deficiency syndrome \[AIDS], leukaemia, lymphoma), cancer therapy (cytotoxic drugs, radiotherapy) or immunosuppressive therapy (e.g. corticosteroids, cyclosporin)

Outcomes

Primary Outcomes

Not specified

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