Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer - Full Text View

Sponsors and Collaborators:	University of Pennsylvania 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

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Motexafin lutetium Motexafin Antrin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Trial of Photodynamic Therapy With Lutetium Texaphyrin in Patients With Locally Recurrent Prostate Carcinoma

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

University of Pennsylvania

National Cancer Institute (NCI)

Investigators

Study Chair:

Stephen Michael Hahn, MD

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.

Study ID Numbers:	CDR0000067672, UPCC-6899, NCI-T99-0042
Study First Received:	April 6, 2000
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00005067 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
recurrent prostate cancer

Study placed in the following topic categories:

Photosensitizing Agents
Radiation-Sensitizing Agents
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

Adenocarcinoma
Motexafin lutetium
Prostatic Neoplasms
Recurrence
Carcinoma

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Physiological Effects of Drugs
Urogenital Neoplasms
Genital Diseases, Male
Pharmacologic Actions
Neoplasms

Photosensitizing Agents
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Prostatic Neoplasms
Motexafin lutetium
Dermatologic Agents

ClinicalTrials.gov processed this record on May 07, 2009