Clinical trial · Interventional
Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer
NCT00322699CI-TRIAL-00008341completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This protocol is evaluating efficacy and toxicity of three sequential whole bladder photodynamic treatment with Photofrin and red laser light (630 nm) in the management of superficial bladder cancer (non-muscle invasive) in those patients who have failed or are not candidates for conventional intravesical therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Superficial Bladder Cancer | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photofrin | Drug | Porfimer | ALIAS |
| Whole bladder laser light treatment as an alternative to radical cystectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A single arm, non-randomized Phase II Study
- description
- Non-Randomized Phase II,Single Arm Study evaluating the efficacy of whole bladder photodynamic therapy as an alternative to radical cystectomy.
- interventionNames
- Procedure: Whole bladder laser light treatment as an alternative to radical cystectomy
- Drug: Photofrin
Primary outcomes (1)
- measure
- Dose Limiting Toxicity
- timeFrame
- 18 months
Secondary outcomes (1)
- measure
- Disease progression
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological diagnosis of bladder cancer, non muscle invasive * Recurrent after at least one course of standard intravesical therapy after transurethral resection (TURBT). * Maximum debulking of tumor by TURBT/fulguration * One or more of the following: * Contraindications to conventional intravesical therapy, including patient's refusal. * Positive or suspicious urine cytology localized to the bladder * Prior intravesical therapy and persistent atypia. * Premalignant (diffuse squamous metaplasia or malakoplakia) lesions. * Bladder capacity greater or equal to 150 cc. * No contraindications to an appropriate anesthesia or analgesia. * Karnofsky's performance status \> 50. * Patients must sign an informed consent form in accordance with the Institution's Review Board and FDA 21 CFR Part 50. * Female patients must be practicing a medically acceptable form of birth control or be sterile or postmenopausal. Exclusion Criteria: * Pregnant or nursing mother. * Known hypersensitivity to porphyrins.
References
Publications (0)
Data not yet available
No reference posted for this study.