Clinical trial NCT00005067: Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer
Official title: A Phase I Trial of Photodynamic Therapy With Lutetium Texaphyrin in Patients With Locally Recurrent Prostate Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 24 hours
measure: MTD based on the incidence of DLT as assessed by the Cancer Therapy Evaluation Program CTC version 2.0
timeFrame: 24 hours
Secondary outcomes:
measure: Percent change in lutetium texaphyrin levels in needle biopsies by high pressure liquid chromatography (HPLC) and tissue fluorescence assay
timeFrame: From pre-PDT to post-PDT
measure: Lutetium texaphyrin levels in situ
timeFrame: At pre- and post-PDT
measure: Clinical response rate defined as no evidence of disease (NED)
timeFrame: Up to 5 years
measure: Progression-free survival (PFS)
timeFrame: From the date of accession to the date of documentation of clinical progression or until the date of death from any cause, assessed up to 5 years
measure: Time to complete response
timeFrame: Up to 5 years
measure: Time to biochemical relapse
timeFrame: Up to 5 years
measure: Time to local progression as determined by clinical exam
timeFrame: From the date of accession to the date of documented local progression, assessed up to 5 years
measure: Time to distant failure
timeFrame: From the date of accession to the date of documented metastatic disease, assessed up to 5 years
measure: Overall survival
timeFrame: From the date of accession to the date of death, assessed up to 5 years
measure: Disease specific survival
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of The University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Stephen Michael Hahn
role: PRINCIPAL_INVESTIGATOR
References: