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Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
pegylated liposomal doxorubicin hydrochloride
hyperthermia treatment
Sponsored by
Imunon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Urology, L.L.C.
  • Grand Strand Urology LLP

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 5, 2003
Last Updated
May 29, 2013
Sponsor
Imunon
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1. Study Identification

Unique Protocol Identification Number
NCT00061867
Brief Title
Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer
Official Title
A Dose Escalation, Pharmacokinetics, and Safety Study of Doxorubicin Encapsulated in Temperature Sensitive Liposomes Released Through Microwave Therapy in the Treatment of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Imunon

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride
Intervention Type
Procedure
Intervention Name(s)
hyperthermia treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Van Doren, RN
Organizational Affiliation
Imunon
Official's Role
Study Chair
Facility Information:
Facility Name
Regional Urology, L.L.C.
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Grand Strand Urology LLP
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States

12. IPD Sharing Statement

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Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer

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