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Sponsors and Collaborators: |
North Florida/South Georgia Veterans Health System Oncologic Foundation of Buffalo (OFB) Axcan Pharma University of Florida |
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Information provided by: | North Florida/South Georgia Veterans Health System |
ClinicalTrials.gov Identifier: | NCT00322699 |
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.
Condition | Intervention | Phase |
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Superficial Bladder Cancer |
Procedure: Photofrin mediated-Whole Bladder Photodynamic Therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer |
Estimated Enrollment: | 25 |
Study Start Date: | February 2005 |
Patient Evaluation and Treatment
Initial patient assessments will include:
WBPDT Treatment:
All WBPDT treatments will occur within 18 months
Decisions to administer a second or third WBPDT will be based upon urological and medical assessment of the individual patient and not necessarily dependent upon Dose Limiting Toxicities (DLT) or early stopping endpoints (although such information may be taken into account in the individual patient assessment). Patients experiencing DLT may continue WBPDT at the investigator’s discretion at the same or reduced doses of Porfimer Sodium and/or light.
The following will be considered Dose Limiting Toxicities (DLT):
Efficacy will be assessed on the basis of the following criteria:
Referred patients will undergo post-PDT cystoscopy by the referring Urologists, who will transmit the results to the study site in Gainesville,Fl.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
One or more of the following:
Exclusion Criteria:
Contact: Unyime O Nseyo, M.D. | (352)3761611 ext 6468 | Unyime.Nseyo2@med.va.gov |
Contact: Maria C Mejia | (352)3761611 ext 6952 | Maria.Mejia@va.gov |
United States, Florida | |
Malcom Randall NF/SG Veterans Administration Health System | Recruiting |
Gainesville, Florida, United States, 32608 | |
Contact: Unyime O Nseyo, M.D. 352-376-1611 ext 6468 Unyime.Nseyo2@med.va.gov | |
Contact: Maria C Mejia (352)3761611 ext 6952 Maria.Mejia@va.gov |
Principal Investigator: | Unyime O Nseyo, M.D. | NF/SGVAHS/UF SCHOOL OF MEDICINE |
Study ID Numbers: | WBPDT-577-04 |
Study First Received: | May 4, 2006 |
Last Updated: | May 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00322699 |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
Bladder Cancer Photodynamic Therapy Photofrin Photosensitization Photoradiation |
Cystocele Urologic Diseases Dihematoporphyrin Ether Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms |
Hematoporphyrin Derivative Trioxsalen Urologic Neoplasms Urinary tract neoplasm Bladder neoplasm |
Photosensitizing Agents Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Dermatologic Agents Pharmacologic Actions |