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Adenocarcinoma of the ProstatePhase 1NCT00005067

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

A Phase 1 study testing motexafin lutetium and photodynamic therapy in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
motexafin lutetium and photodynamic therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Feb 2000to Jan 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 26Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center of The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
motexafin lutetium, photodynamic therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • motexafin lutetiumDrug

    Also called Antrin, lutetium texaphrin, lutetium texaphyrin, Lutex

    Given IV

  • photodynamic therapyDrug

    Also called Light Infusion Therapy™, PDT, therapy, photodynamic

    Undergo photodynamic therapy

Study groups in NCT00005067
Study groupRoleWhat they receive
Treatment (motexafin lutetium, PDT)ExperimentalPatients 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.
Receives: Drug: motexafin lutetium; Drug: photodynamic therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 hours

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

    Measured: 24 hours

Secondary outcomes (10)

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

    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.

    Measured: From pre-PDT to post-PDT

  2. Lutetium texaphyrin levels in situ

    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.

    Measured: At pre- and post-PDT

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

    The 95% confidence interval will be calculated for the rate of NED.

    Measured: Up to 5 years

  4. Progression-free survival (PFS)

    Estimated by the method of Kaplan and Meier.

    Measured: 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

  5. Time to complete response

    Measured: Up to 5 years

  6. Time to biochemical relapse

    Measured: Up to 5 years

  7. Time to local progression as determined by clinical exam

    Estimated by the method of Kaplan and Meier.

    Measured: From the date of accession to the date of documented local progression, assessed up to 5 years

  8. Time to distant failure

    Measured: From the date of accession to the date of documented metastatic disease, assessed up to 5 years

  9. Overall survival

    Measured: From the date of accession to the date of death, assessed up to 5 years

  10. Disease specific survival

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2000
  3. Primary completionJan 2007

Why it stopped: Administratively complete.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005067
Sponsor's protocol ID
NCI-2012-02323
Other IDs
UPCC 6899, CDR0000067672
Status last verified
Jan 2013
First submitted
6 Apr 2000
Last updated
16 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing motexafin lutetium and photodynamic therapy in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.

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