Prostate CancerPhase 1NCT00061867
Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer
A Phase 1 study testing pegylated liposomal doxorubicin hydrochloride and hyperthermia treatment in people with Prostate Cancer, run by Imunon at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- pegylated liposomal doxorubicin hydrochloride and hyperthermia treatment
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Mar 2003to Aug 2005
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grand Strand Urology LLP
Myrtle Beach, South Carolina, 29572
Regional Urology, L.L.C.
Shreveport, Louisiana, 71106
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- pegylated liposomal doxorubicin hydrochloride, hyperthermia treatment
- Keywords
- adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated liposomal doxorubicin hydrochlorideDrug
hyperthermia treatmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2003 (estimated)
- Study startMar 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Imunon
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Catherine Van Doren, RN, Study chair, Imunon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061867
- Sponsor's protocol ID
- CELSION-10302101
- Other IDs
- CDR0000301761, RPCI-DS-0228
- Status last verified
- Jul 2005
- First submitted
- 5 Jun 2003
- Last updated
- 30 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00061867
- Acronym / sponsor ID
- CELSION-10302101
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- ImunonIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Aug 2005 (actual)
- First posted
- 6 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegylated liposomal doxorubicin hydrochloride | Drug | – |
| hyperthermia treatment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Van Doren, RN study chair
Imunon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pegylated liposomal doxorubicin hydrochloride and hyperthermia treatment in people with Prostate Cancer, run by Imunon at 2 sites 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?
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: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 30 May 2013.