A Phase I Trial of Photodynamic Therapy With Lutetium Texaphyrin in Patients With Locally Recurrent Prostate Carcinoma
I. 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.
I. 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.
II. 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.
III. 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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity (DLT) defined as grade III non-hematologic toxicity or grade IV hematologic toxicity as assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) version 2.0
Stephen Michael Hahn
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
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