Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Urinary Bladder Neoplasms

Urologic Neoplasms

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Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Dermatologic Agents

All Drugs and Chemicals

Central Nervous System Depressants

Dihematoporphyrin Ether

Trioxsalen

Hematoporphyrin Derivative

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Hematoporphyrins

Photosensitizing Agents

Non-Randomized Phase II,Single Arm Study evaluating the efficacy of whole bladder photodynamic therapy as an alternative to radical cystectomy.

The drug,Photofrin,at the dose of 1.5 mg/kg is infused intravenously two days prior to performing whole bladder laser light (630 nm) treatment.

Whole bladder laser light treatment as an alternative to radical cystectomy

Photofrin

Unyime O Nseyo, M.D.

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.

Patient Evaluation and Treatment:

1. Patients will sign an IRB-approved informed consent form
2. Initial patient assessments will include:

   * eligibility
   * History and physical.
   * clinical profile
   * upper urinary tract imaging (if clinically indicated)
   * urinary symptoms assessment

WBPDT Treatment:

1. Porfimer Sodium (Photofrin) 1.5 mg/kg iv followed 2 days later by whole bladder laser light at 630 nm with target light doses of 1200 Joules (+/-100Joules)
2. Patients will undergo three sequential WBPDT treatments
3. Treatments will occur at least three months apart
4. All WBPDT treatments will occur within 12 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):
   * Urinary symptoms grade 3, or more over 12 weeks duration (see section 7 for toxicity grading)
   * Loss of \> 50% of baseline bladder volume
   * Clinical decision of investigator or patient to discontinue due to toxicity.

   Efficacy will be assessed on the basis of the following criteria:
   * Complete Response: cystoscopy with biopsy and/or cytology without evidence of cancer.
   * Partial Response: normal cystoscopy and biopsies, if obtained, but persistent positive or suspicious cytology localized to the bladder; or, for patients with CIS, \> 50% reduction in extent of CIS.
   * Persistent/Recurrent Disease: persistent or recurrent cancer of the same or lesser stage and grade as at enrollment without obvious increase in tumor burden.
   * Progression: cancer of any greater stage or grade than at enrollment or obvious increase in tumor burden.

   Referred patients will undergo post-PDT cystoscopy by the referring Urologists, who will transmit the results to the study site in Gainesville,Fl.
5. Symptoms will be assessed for one month following each WBPDT by weekly telephone contact.
6. Urine and blood for cytokines will be obtained before each treatment and possibly twice afterwards and stored -80oF for analysis later.
7. Biopsy specimen samples from tumor and normal bladder may be obtained at cystoscopy and stored for later analysis for biomarkers.
8. Patients will be followed for toxicity, disease status, urinary tract symptoms, and survival.

Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer

North Florida Foundation for Research and Education

Axcan Pharma

North Florida/South Georgia Veterans Health System

PHYSICIAN

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Aminolevulinic Acid

Cola

Participants receive neoadjuvant 5-ALA and PDT.

Patients receive neoadjuvant PDT with radiosensitizing 5-ALA 4 days prior to surgery for colon cancer.

PDT with 5-ALA radiosensitization

Randall F Holcombe, MD

Edward L Nelson, MD

The central hypothesis for this study is that it is safe and feasible to administer intraluminal photodynamic therapy (PDT) to colon cancers by colonoscopy to induce localized inflammatory/immune response. The objective is to demonstrate the feasibility and safety of PDT to colon cancer patients administered before surgery and to characterize the inflammatory/immune response at the tumor site and systemically. The long-term objective of these studies is to modify he natural biology of colorectal cancers and improve patient survival.

The central hypothesis for this study is that it is safe and feasible to administer intraluminal photodynamic therapy (PDT) to colon cancers, via colonoscopy, in the neoadjuvant setting to induce localized tumor cell death and an inflammatory/immune response with an increased Th1 component, utilizing 5-ALA as a photosensitizer. The objective is to conduct an initial phase I/II clinical study to demonstrate the feasibility and safety of colonoscopic, neoadjuvant intraluminal PDT to colon cancer patients administered 96 hours pre-resection, to characterize the inflammatory/immune response at the PDT treated tumor site, and to evaluate the systemic anti-tumor immune response. The long-term objective of these studies is to provide an easily administered, adjunctive, therapeutic maneuver that lacks systemic toxicity, with the potential to modulate the natural biology of colorectal cancers that have not elicited a favorable anti-tumor immune response and to improve patient survival.

A Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer

A Phase I/II Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer

Define biologic efficacy of PDT in relation to generation of an immune response at the tumor site and systemically. This will be measured by degree of dendritic cell infiltration into tumor and regional lymph nodes, and degree of systemic immunity directed against colon cancer antigens immediately post procedure and after 6 months.

Safety will be evaluated from enrollment through 6 months. This will be measured by proportion of patients completing planned surgery, proportion of patients experiencing grade 3 or 4 toxicities, and lack of observation of serious adverse events related to the study procedure.

Quality of life will be evaluated 6 months following completion of participation in the study

Immunologic parameters will be monitored following completion of the study as a measure of sustained immunity

University of California, Irvine

National Cancer Institute (NCI)

Edward Nelson

Dr. Edward Nelson

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer	NCT00322699	Superficial Bla...	Whole bladder l... Photofrin	18 Years -	North Florida/South Georgia Veterans Health System
A Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer	NCT01522677	Colon Cancer	PDT with 5-ALA ...	18 Years -	University of California, Irvine
Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer	NCT00322699	Superficial Bla...	Whole bladder l... Photofrin	18 Years -	North Florida/South Georgia Veterans Health System

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