Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer

Stopped early · Phase 1

Conditions studied: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

In brief

This phase I trial is studying the side effects and best dose of photodynamic therapy with lutetium texaphyrin in treating patients with locally recurrent prostate cancer. 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

Key facts

Study ID

NCT00005067

Run by

National Cancer Institute (NCI)

People needed

24

Starts

2000-02-01

Last updated by the study team

2013-01-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Performance status - ECOG 0-2
• WBC at least 2,000/mm\^3
• Platelet count at least 100,000/mm\^3
• No severe liver disease (e.g., cirrhosis or grade III-IV elevations in liver function studies)
• Bilirubin no greater than 1.5 mg/dL
• Creatinine normal
• Creatinine clearance at least 60 mL/min
• 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
• At least 4 weeks since prior gene therapy
• At least 4 weeks since prior immunotherapy
• At least 4 weeks since prior combination chemotherapy
• No concurrent chemotherapy
• At least 4 weeks since prior hormonal therapy
• No concurrent hormonal therapy
• No prior cryosurgery for prostate cancer

Where it is running

• Abramson Cancer Center of The University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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