Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer

May 29, 2013 updated by: Imunon

A Dose Escalation, Pharmacokinetics, and Safety Study of Doxorubicin Encapsulated in Temperature Sensitive Liposomes Released Through Microwave Therapy in the Treatment of Prostate Cancer

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, use different ways to stop tumor cells from dividing so they stop growing or die. Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. Combining liposomal doxorubicin with microwave thermotherapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of liposomal doxorubicin when given together with microwave thermotherapy in treating patients with prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of doxorubicin HCl liposome released through thermal microwave therapy in patients with adenocarcinoma of the prostate.
  • Determine the pharmacokinetics and biodistribution profile of this drug in these patients.
  • Determine the safety profile and dose-limiting toxicity of this drug in these patients.
  • Determine the clinical response in patients treated with this regimen.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive doxorubicin HCl liposome IV over 30 minutes. Patients then undergo a 60-minute course of prostate thermotherapy. Treatment may repeat every 28-42 days for up to 6 courses, at the discretion of the physician.

Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 8, 15, 30, and 90 days.

PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology, L.L.C.
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Grand Strand Urology LLP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Rising prostate-specific antigen AND radiographic evidence of extraprostatic prostate cancer by bone scan, CT scan, prostascint scan, or MRI

PATIENT CHARACTERISTICS:

Age

  • 40 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 10.0 g/dL

Hepatic

  • Bilirubin normal
  • AST normal
  • Alkaline phosphatase normal
  • No acute or chronic liver disease

Renal

  • Creatinine less than 1.5 times upper limit of normal

Cardiovascular

  • Ejection fraction at least 50% by MUGA
  • EKG normal
  • No myocardial infarction or cerebral vascular accident within the past 6 months
  • No life threatening cardiac arrhythmias
  • No congestive heart failure
  • No cardiac pacemaker
  • No peripheral arterial disease with intermittent claudication or Leriches syndrome (i.e., claudication of the buttocks or perineum)

Other

  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • No sperm donation during and for 3 months after study participation
  • Not febrile
  • No interest in future fertility or fathering children
  • No significantly decreased pain response
  • No severe urethral stricture
  • No protruding median lobe resulting in a "ball-valve" type of obstruction at the bladder neck
  • No major psychiatric illness that would prevent informed consent
  • No major psychiatric illness that required inpatient treatment within the past 3 months
  • No psychological, family, sociological, or geographic condition that would preclude study compliance
  • No allergy to eggs or egg products
  • No urinary or prostatic infection
  • No full urinary retention
  • No penile or urinary sphincter implant
  • No metallic implants in the pelvic or femoral area
  • No other serious medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent live vaccines

Chemotherapy

  • No prior anthracycline
  • No concurrent streptozocin

Endocrine therapy

  • No concurrent hormonal therapy (except luteinizing hormone-releasing hormone analog)
  • No concurrent glucocorticoids administered at more than physiologic replacement doses (other than as an antiemetic)

Radiotherapy

  • Not specified

Surgery

  • More than 3 months since prior major surgery

Other

  • No prior therapy that resulted in permanent reduction of pain response (e.g., prior surgery, regional or local anesthetic)
  • No concurrent PC-SPES
  • No concurrent cyclosporine, phenobarbital, or phenytoin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imunon

Investigators

  • Study Chair: Catherine Van Doren, RN, Imunon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

June 5, 2003

First Submitted That Met QC Criteria

June 5, 2003

First Posted (Estimate)

June 6, 2003

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELSION-10302101
  • CDR0000301761 (Registry Identifier: PDQ (Physician Data Query))
  • RPCI-DS-0228

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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