A Phase I Trial of Photodynamic Therapy With Lutetium Texaphyrin in Patients With Locally Recurrent Prostate Carcinoma
18 Years
N/A
Male
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
Trial Information
A Phase I Trial of Photodynamic Therapy With Lutetium Texaphyrin in Patients With Locally Recurrent Prostate Carcinoma
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
Inclusion Criteria:
- 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
- No other concurrent medication for prostate cancer
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
24 hours
Safety Issue:
Yes
Principal Investigator
Stephen Michael Hahn
Investigator Role:
Principal Investigator
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02323
NCT ID:
NCT00005067
Start Date:
February 2000
Completion Date:
Related Keywords:
- Adenocarcinoma of the Prostate
- Recurrent Prostate Cancer
- Stage I Prostate Cancer
- Stage IIA Prostate Cancer
- Stage IIB Prostate Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
