NCT00005067

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

6.9 years

First QC Date

April 6, 2000

Last Update Submit

January 15, 2013

Conditions

Adenocarcinoma of the ProstateRecurrent Prostate CancerStage I Prostate CancerStage IIA Prostate CancerStage IIB Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

    24 hours

  • MTD based on the incidence of DLT as assessed by the Cancer Therapy Evaluation Program CTC version 2.0

    24 hours

Secondary Outcomes (10)

  • Percent change in lutetium texaphyrin levels in needle biopsies by high pressure liquid chromatography (HPLC) and tissue fluorescence assay

    From pre-PDT to post-PDT

  • Lutetium texaphyrin levels in situ

    At pre- and post-PDT

  • Clinical response rate defined as no evidence of disease (NED)

    Up to 5 years

  • Progression-free survival (PFS)

    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

  • Time to complete response

    Up to 5 years

  • +5 more secondary outcomes

Study Arms (1)

Treatment (motexafin lutetium, PDT)

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.

Drug: motexafin lutetiumDrug: photodynamic therapy

Interventions

motexafin lutetiumDRUG

Given IV

Also known as: Antrin, lutetium texaphrin, lutetium texaphyrin, Lutex, PCI-0123
Treatment (motexafin lutetium, PDT)
photodynamic therapyDRUG

Undergo photodynamic therapy

Also known as: Light Infusion Therapy™, PDT, therapy, photodynamic
Treatment (motexafin lutetium, PDT)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

motexafin lutetiumPhotochemotherapy1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Stephen Michael Hahn

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2000

First Posted

January 27, 2003

Study Start

February 1, 2000

Primary Completion

January 1, 2007

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)