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: Phase I trial to study the effectiveness of combining liposomal doxorubicin with microwave thermotherapy in treating patients who have prostate cancer.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer	Drug: doxorubicin HCl liposome  Procedure: chemotherapy  Procedure: hyperthermia	Phase I

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.

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

William E. Gannon, MD,  Study Chair,  Celsion   

Study ID Numbers:  CDR0000301761; CELSION-10302101; RPCI-DS-0228
Record last reviewed:  July 2004
Record first received:  June 5, 2003
ClinicalTrials.gov Identifier:  NCT00061867
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-16