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Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer Clinical research trials and Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer. Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer clinical trial. Human subjects often get the best healthcare available for their Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer  Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer
Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer
For Condition: stage 1 prostate cancer,adenocarcinoma of the prostate,stage 2 prostate cancer,recurrent prostate cancer
Status: Recruiting
Sponsor(s): University of Pennsylvania Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for locally recurrent prostate cancer. Photosensitizing drugs, such as lutetium texaphyrin, are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells. PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with lutetium texaphyrin in treating patients who have locally recurrent prostate cancer.
Details: OBJECTIVES: Primary - Determine the dose limiting toxicities and maximum tolerated dose of photodynamic therapy (PDT) using 730 nm light and lutetium texaphyrin in patients with locally recurrent prostate adenocarcinoma who have failed previous definitive radiotherapy. Secondary - Measure lutetium texaphyrin levels in needle biopsies of the prostate before and after PDT using an HPLC and tissue fluorescence assay and calculate the percent change in lutetium texaphyrin after treatment. - Measure lutetium texaphyrin fluorescence in situ in the prostate before and after PDT using optical methods and correlate these results with the direct tissue measurements made in the biopsies of these patients. - Determine clinical outcome including clinical response, progression free survival, time to complete response, time to biochemical relapse, time to local progression, time to distant failure, overall survival, and disease specific survival in these patients treated with this regimen. OUTLINE: This is a dose-escalation study of lutetium texaphyrin and light fluence. Patients receive lutetium texaphyrin IV over 10-15 minutes 3-24 hours before photodynamic therapy (PDT). Optical fibers attached to a laser are inserted through a catheter into the prostate. The laser delivers 730 nm light to the prostate until the specified fluence is delivered. Patients undergo biopsy of the prostate and bladder before and after PDT. Cohorts of 3-6 patients receive escalating doses of lutetium texaphyrin and light fluence until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed at 2 weeks, 1 month, 2 months, 3 months, then every 3 months until 2 years, then every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven locally recurrent prostate adenocarcinoma previously treated with definitive radiotherapy - No T3 or T4 primary tumors - No evidence of regional or distant metastases by MRI or bone scan - No pathologic demonstration of malignancy in pelvic or abdominal lymph nodes - Prostate gland volume no greater than 50 mL by MRI or ultrasound - PSA no greater than 20 ng/mL PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - No severe liver disease (e.g., cirrhosis or grade III-IV elevations in liver function studies) - Bilirubin no greater than 1.5 mg/dL Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Other: - Medical suitability for implantation - Fertile patients must use effective contraception during and for 6 months after study participation - No history of grade III or IV genitourinary or gastrointestinal toxicity - No known G6PD deficiency - No porphyria PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior gene therapy - At least 4 weeks since prior immunotherapy Chemotherapy: - At least 4 weeks since prior combination chemotherapy - No concurrent chemotherapy Endocrine therapy: - At least 4 weeks since prior hormonal therapy - No concurrent hormonal therapy Radiotherapy: - See Disease Characteristics Surgery: - No prior cryosurgery for prostate cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenHahn, Study Chair, University of Pennsylvania Cancer Center
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting S. Malkowicz 215-662-7330
Additional Information:
Study ID Numbers: CDR0000067672; UPCC-T99-0042,NCI-T99-0042
Study Start Date:
Record last reviewed: April 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005067
Other Stage 2 Prostate Cancer Studies:
1. Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
2. Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
3. Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
4. Radiation Therapy in Treating Patients With Prostate Cancer
5. Diet and PSA Levels in Patients With Prostate Cancer
Related Studies:
Other stage 2 prostate cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer
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