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


Phase 1
40 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Catherine Van Doren, RN

Investigator Role:

Study Chair

Investigator Affiliation:

Celsion

Authority:

United States: Federal Government

Study ID:

CELSION-10302101

NCT ID:

NCT00061867

Start Date:

March 2003

Completion Date:

August 2005

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Regional Urology, L.L.C.Shreveport, Louisiana  71101
Grand Strand Urology LLPMyrtle Beach, South Carolina  29572