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Liver CancerPhase 1NCT00093444

Heat Activated Liposomal Doxorubicin and Radiofrequency Ablation in Treating Patients With Primary or Metastatic Liver Tumors

A Phase 1 study testing lyso-thermosensitive liposomal doxorubicin and radiofrequency ablation in people with Liver Cancer and Metastatic Cancer, run by National Institutes of Health Clinical Center (CC) at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cancer, Metastatic Cancer
What is being tested?
lyso-thermosensitive liposomal doxorubicin and radiofrequency ablation
Type of treatment
Surgery or procedure
How many people
30 participants
Where
2 sitesin 2 countries
Study dates
Sep 2004to Jan 2010
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed tumor of the liver
  • Primary or metastatic disease
  • No more than 4 lesions
  • No single lesion > 7 cm in maximum diameter
  • Not a candidate for curative surgical resection due to tumor histology or prior surgery

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Platelet count ≥ 75,000/mm^3
  • WBC ≥ 1,500/mm^3
  • Hemoglobin ≥ 10 g/dL (transfusions to attain levels ≥ 10g/dL allowed)

Hepatic

  • Bilirubin ≤ 2.0 mg/dL
  • PT or PTT ≤ 1.5 times control (except for patients receiving anticoagulation therapy for an unrelated medical condition [e.g., atrial fibrillation])

Renal

  • Creatinine ≤ 2.5 mg/dL

Cardiovascular

  • See Hepatic
  • Ejection fraction ≥ 50% by MUGA
  • No congestive heart failure
  • No myocardial infarction within the past 6 months
  • No cerebral vascular accident within the past 6 months
  • No life-threatening cardiac arrhythmia

Other

  • Weight < 136 kg
  • Glucose ≤ 300 mg/dL
  • No uncontrolled diabetes
  • No known serious uncontrolled reaction (e.g., anaphylaxis) to contrast agents used in this study
  • No known allergy to egg or egg products
  • No other serious medical illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent interferon
  • No live vaccines (for immunosuppressed patients only) during and for 30 days after study treatment

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Other

  • More than 3 weeks since prior therapy for liver tumor(s)
  • More than 3 weeks since prior systemic therapy for non-life-threatening extrahepatic disease and recovered
  • No other concurrent systemic therapy
  • No administration of any of the following medications during and for 30 days after study treatment:
  • Cyclosporine
  • Phenobarbital
  • Phenytoin
  • Streptozocin
  • No concurrent administration of any of the following medications:
  • Amphotericin B by injection
  • Antithyroid agents for overactive thyroid
  • Azathioprine
  • Chloramphenicol
  • Colchicine
  • Flucytosine
  • Ganciclovir
  • Plicamycin
  • Zidovudine
  • Probenecid
  • Sulfinpyrazone

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892-1182

Other trials in United States

China1 site

  • Queen Mary Hospital - Hong Kong

    Hong Kong

Other trials in China

About this study

Official title: A Phase I Dose Escalation Study Of Heat Activated Liposome Delivery Of Doxorubicin And Radiofrequency Ablation Of Primary And Metastatic Tumors Of The Liver

RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with liposomal doxorubicin may increase the effectiveness of the drug and kill more tumor cells.

PURPOSE: This phase I trial is studying the best dose of liposomal doxorubicin when given with radiofrequency ablation in treating patients with primary or metastatic liver tumors.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of heat activated doxorubicin HCl liposome when combined with radiofrequency ablation in patients with primary or metastatic tumors of the liver.
  • Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

OUTLINE: This is a dose-escalation study of heat activated doxorubicin HCl liposome.

Patients receive doxorubicin HCl liposome IV over 30 minutes. Approximately 15 minutes after the beginning of the doxorubicin HCl liposome infusion, patients undergo radiofrequency ablation with needles inserted into the tumor(s) and heated to the target temperature for approximately 12-60 minutes.

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

Patients are followed at 28 days, every 3 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 2 years.

Being tested
lyso-thermosensitive liposomal doxorubicin, radiofrequency ablation
Keywords
advanced adult primary liver cancer, liver metastases, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
Medical subject headings
Liver Neoplasms, Neoplasm Metastasis, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lyso-thermosensitive liposomal doxorubicinDrug

  • radiofrequency ablationProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose of heat-activated doxorubicin HCL liposome

  2. Pharmacokinetics and pharmacodynamics of heat-activated doxorubicin HCL liposome at 15, 30, 45, 60, 75, and 90 minutes; 2, 3, 4, 6, 24, and 46 hours; and 4 and 8 days following infusion

Secondary outcomes (1)

  1. Effects of ablative therapy on tumor blood flow and tumor vascular density as measured by MRI at 28 days following study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2004 (estimated)
  2. Study startSep 2004
  3. Study completionJan 2010

Resources

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
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00093444
Sponsor's protocol ID
040263
Other IDs
04-C-0263, CELSION-10403101, CDR0000387979
Status last verified
Mar 2012
First submitted
6 Oct 2004
Last updated
15 Mar 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lyso-thermosensitive liposomal doxorubicin and radiofrequency ablation in people with Liver Cancer and Metastatic Cancer, run by National Institutes of Health Clinical Center (CC) at 2 sites in 2 countries.

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 15 Mar 2012. 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, China. 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.

What does the primary outcome measure?

Maximum tolerated dose of heat-activated doxorubicin HCL liposome. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00093444.

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 15 Mar 2012.

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