Intermediate or High-risk Bladder Cancer Clinical Trial
Official title:
A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk Bladder Cancer
Verified date | February 2011 |
Source | Photocure |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate based photodynamic therapy in patients with intermediate or high-risk transitional cell carcinoma of the bladder.
Status | Completed |
Enrollment | 17 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female aged 18 years or above who have given written informed consent. - Patients with intermediate or high-risk superficial bladder cancer, defined as low-grade early recurrence within 6 months after local chemotherapy or BCG, primary or recurrent high-grade disease (TaG3, TaG3 with CIS or CIS alone) or patients with primary T1G3 who are tumour free at second resection. Exclusion Criteria: - Patients with muscle invasive tumour - Patients with bladder shrinkage - Patients who have received prior PDT for bladder cancer - History of T1G3 disease or other indications for cystectomy - Patient with porphyria - Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with PDT) - Patients who have received BCG or chemotherapy within three months prior to Hexvix instillation, except for a single dose of chemotherapy for prevention of seeding after resection - Known allergy to hexaminolevulinate or a similar compound - Participation in other clinical studies either concurrently or within the last 30 days - Women of child-bearing potential. - Conditions associated with a risk of poor protocol compliance |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Photocure | Karl Storz |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with adverse events | To assess the safety of photodynamic therapy (PDT) using Hexvix and the Karl Storz T-light PDT System in patients with recurrent bladder cancer. (assessment of adverse events, blood biochemistry, vital signs, urodynamics) |
Yes | |
Secondary | The number of tumour-free patients after 6 months | To assess the efficacy of Hexvix PDT in patients with intermediate and high-risk bladder cancer | No |