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

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005067
First received: April 6, 2000
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Drug: motexafin lutetium
Drug: photodynamic therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of Photodynamic Therapy With Lutetium Texaphyrin in Patients With Locally Recurrent Prostate Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • MTD based on the incidence of DLT as assessed by the Cancer Therapy Evaluation Program CTC version 2.0 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent change in lutetium texaphyrin levels in needle biopsies by high pressure liquid chromatography (HPLC) and tissue fluorescence assay [ Time Frame: From pre-PDT to post-PDT ] [ Designated as safety issue: No ]
    Scattergrams and error bar plots of lutetium texaphyrin concentration by lutetium texaphyrin dose level and possibly by light fluence (for a fixed lutetium texaphyrin dose = 2) will be constructed to investigate possible dose-concentration relationships.

  • Lutetium texaphyrin levels in situ [ Time Frame: At pre- and post-PDT ] [ Designated as safety issue: No ]
    Descriptive statistics (mean, median, standard deviation, range and coefficient of variation) will be used to characterize the distribution of lutetium texaphyrin concentrations within each dose level.

  • Clinical response rate defined as no evidence of disease (NED) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The 95% confidence interval will be calculated for the rate of NED.

  • Progression-free survival (PFS) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Estimated by the method of Kaplan and Meier.

  • Time to complete response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Time to biochemical relapse [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Time to local progression as determined by clinical exam [ Time Frame: From the date of accession to the date of documented local progression, assessed up to 5 years ] [ Designated as safety issue: No ]
    Estimated by the method of Kaplan and Meier.

  • Time to distant failure [ Time Frame: From the date of accession to the date of documented metastatic disease, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From the date of accession to the date of death, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Disease specific survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2000
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: motexafin lutetium
Given IV
Other Names:
  • Antrin
  • lutetium texaphrin
  • lutetium texaphyrin
  • Lutex
  • PCI-0123
Drug: photodynamic therapy
Undergo photodynamic therapy
Other Names:
  • Light Infusion Therapy™
  • PDT
  • therapy, photodynamic

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005067

Locations
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: Stephen Michael Hahn Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005067     History of Changes
Other Study ID Numbers: NCI-2012-02323, UPCC 6899, CDR0000067672
Study First Received: April 6, 2000
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms
Motexafin lutetium
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014