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A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma

Phase 1/Phase 2
18 Years
Not Enrolling
Bladder Cancer

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Trial Information

A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma

Inclusion Criteria:

- Histologically proven diagnosis of transitional cell carcinoma of the bladder

- ECOG 0-2

- 18 years of age or older

- signed informed consent

- for the Phase I part: patient scheduled for cystectomy

Exclusion Criteria:

- Woman of childbearing potential (fertile woman)

- Other malignancy within 5 years of study, except for non-melanoma skin cancer

- Metastatic disease

- Previous exposure to any intravesical therapy for bladder cancer: within 3 months for
chemotherapy and within 6 months for BCG therapy.

- Previous pelvic radiation or treatment with any cytotoxic, immunologic or
chemotherapeutic agent for non-malignant conditions within 5 years of study.

- Clinically abnormal hepatic, renal or bone marrow function, or coagulation disorders
in the opinion of the investigator.

- Chronic urinary tract infections.

- Serous infection of G.U. surgery, except for bladder cancer, within 1 month of study
requiring more than 3 days of hospital care.

- Vesical capacity <150mL and/or vesical obstruction with residual >150 mL after
spontaneous voiding.

- Previous exposure to any experimental drug within 3 months from enrolment.

- Any significant medical or psychiatric illness that would prevent the patient from
giving informed consent of from following the study procedures.

- Patients who presently have urothelial cell carcinoma of the upper G.U. tract

- Patients with systemic autoimmune disease

- Patients that do not consent to that tissue and blood samples are stored in a biobank

- Treatment with systemically administered corticosteroids and NSAID within 4 weeks
prior to first study treatment

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

Continously during therapy and at follow up 30d

Safety Issue:


Principal Investigator

Per-Uno Malmstrom, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Uppsala University Hospital, Uppsala, Sweden


Sweden: Medical Products Agency

Study ID:




Start Date:

November 2006

Completion Date:

October 2009

Related Keywords:

  • Bladder Cancer
  • Urinary Bladder Neoplasms