Suspended

A Phase I Trial of Photodynamic Therapy With Lutetium Texaphyrin in Patients With Locally Recurrent Prostate Carcinoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

motexafin lutetium

+ photodynamic therapy

Drug
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2000
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 16, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2000

Actual date on which the first participant was enrolled.

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.

NCT00005067
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 16, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

Criteria

26 inclusion criteria required to participate
At least 4 weeks since prior combination chemotherapy
At least 4 weeks since prior gene therapy
At least 4 weeks since prior hormonal therapy
At least 4 weeks since prior immunotherapy
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, United StatesOpen Abramson Cancer Center of The University of Pennsylvania in Google Maps
SuspendedOne Study Center