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Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer
This study has been completed.

First Received on April 6, 2000.   Last Updated on February 18, 2011   History of Changes
Sponsor: Abramson Cancer Center of the University of Pennsylvania
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005067
  Purpose

RATIONALE: 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.

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.


Condition Intervention Phase
Prostate Cancer
 Drug: motexafin lutetium
 Phase I

Study Type: Interventional
Study Design: 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:

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Motexafin lutetium Motexafin Antrin
U.S. FDA Resources

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

Primary Outcome Measures:
  • Dose-limiting toxicity and the maximum tolerated dose from the time of drug administration to 1 month [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lutetium texaphyrin levels in needle biopsies by high pressure liquid chromatography (HPLC) and tissue fluorescence assay before and after photodynamic therapy (PDT) and after surgery [ Designated as safety issue: No ]
  • Lutetium texaphyrin fluorescence by optical methods correlated to direct tissue measurements made in biopsies with HPLC and tissue fluorescence before and after PDT [ Designated as safety issue: No ]
  • Optical properties and absorption spectrum of the prostate by optical methods before and after PDT [ Designated as safety issue: No ]
  • Lutetium texaphyrin levels by HPLC and tissue fluorescence before and after PDT [ Designated as safety issue: No ]
  • Percentage of change in lutetium texaphyrin before and after PDT [ Designated as safety issue: No ]
  • Clinical response periodically until disease recurrence [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Time to complete response [ Designated as safety issue: No ]
  • Time to biochemical relapse [ Designated as safety issue: No ]
  • Time to local progression [ Designated as safety issue: No ]
  • Time to distant failure [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Disease specific survival [ Designated as safety issue: No ]
  • In-vivo tissue optical properties, photosensitizer concentration, tissue blood oxygenation, and blood flow by multi-modality optical instrument before, during, and after PDT [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: February 2000
Detailed Description:

OBJECTIVES:

Primary

  • 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

  • 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.
  • 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.
  • 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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • No severe liver disease (e.g., cirrhosis or grade III-IV elevations in liver function studies)
  • Bilirubin no greater than 1.5 mg/dL

Renal

  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior gene therapy
  • At least 4 weeks since prior immunotherapy

Chemotherapy

  • At least 4 weeks since prior combination chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • At least 4 weeks since prior hormonal therapy
  • No concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics

Surgery

  • No prior cryosurgery for prostate cancer

Other

  • No other concurrent medication for prostate cancer
  Contacts and Locations
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, 19104-4283
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
Investigators
Study Chair: Stephen Michael Hahn, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Zhu TC, Finlay JC, Hahn SM. Determination of the distribution of light, optical properties, drug concentration, and tissue oxygenation in-vivo in human prostate during motexafin lutetium-mediated photodynamic therapy. J Photochem Photobiol B. 2005 Jun 1;79(3):231-41. Epub 2004 Dec 2.
Stripp DCH, Mick R, Zhu TC, et al.: Phase I trial of motexafin-lutetium-mediated interstitial photodynamic therapy in patients with locally recurrent prostate cancer. In: Proceedings of SPIE. 5315: 88, 2004.
Zhu TC, Dimofte A, Finlay JC, Stripp D, Busch T, Miles J, Whittington R, Malkowicz SB, Tochner Z, Glatstein E, Hahn SM. Optical properties of human prostate at 732 nm measured in mediated photodynamic therapy. Photochem Photobiol. 2005 Jan-Feb;81(1):96-105.
Patel H, Mick R, Finlay J, Zhu TC, Rickter E, Cengel KA, Malkowicz SB, Hahn SM, Busch TM. Motexafin lutetium-photodynamic therapy of prostate cancer: short- and long-term effects on prostate-specific antigen. Clin Cancer Res. 2008 Aug 1;14(15):4869-76.
Altschuler MD, Zhu TC, Li J, Hahn SM. Optimized interstitial PDT prostate treatment planning with the Cimmino feasibility algorithm. Med Phys. 2005 Dec;32(12):3524-36.

ClinicalTrials.gov Identifier: NCT00005067     History of Changes
Other Study ID Numbers: CDR0000067672, UPCC-6899, NCI-T99-0042
Study First Received: April 6, 2000
Last Updated: February 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
 Motexafin lutetium
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012



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