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

NCT ID: NCT00005067

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29

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.

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (motexafin lutetium, PDT)

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.

Group Type: EXPERIMENTAL

motexafin lutetium

Intervention Type: DRUG

Given IV

photodynamic therapy

Intervention Type: DRUG

Undergo photodynamic therapy

Interventions

motexafin lutetium

Given IV

Intervention Type: DRUG

photodynamic therapy

Undergo photodynamic therapy

Intervention Type: DRUG

Other Intervention Names

Antrin; lutetium texaphrin; lutetium texaphyrin; Lutex; PCI-0123; Light Infusion Therapy™; PDT; therapy, photodynamic

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Michael Hahn

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 6899

Identifier Type: -

Identifier Source: secondary_id

CDR0000067672

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02323

Identifier Type: -

Identifier Source: org_study_id