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Hepatocellular CarcinomaPhase 1NCT00441376

A Study of ThermoDox™ in Combination With Radiofrequency Ablation (RFA) in Primary and Metastatic Tumors of the Liver

A Phase 1 study testing ThermoDox in people with Hepatocellular Carcinoma and Liver Neoplasms, run by Imunon at 1 site in United States.

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

The purpose of this study is to determine the maximum tolerated dose (MTD) of ThermoDox when used in combination with radiofrequency ablation (RFA) in the treatment of primary and metastatic tumors of the liver. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma, Liver Neoplasms
What is being tested?
ThermoDox
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Feb 2007to Dec 2009
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

Who may be able to join

  • Be 18 years of age or older.
  • Are willing to sign an informed consent form, indicating that they are aware of the investigational nature of this study that is in keeping with the policies of the institution.
  • Have a diagnosis of metastatic liver cancer (MLC) or primary hepatocellular cancer (HCC) confined to the liver.
  • Be an appropriate candidate for receiving RFA as a medically indicated treatment.
  • Have an echocardiogram revealing an Ejection Fraction (EF) ≥ 50%.
  • Willing to return to the study site for their imaging scans.
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  • Have life expectancy of ≥ 3 months.
  • Have ECOG performance status of 0-2 or Karnofsky score of 60-100% (see Appendix II).
  • Have no more than Childs-Pugh Class B liver disease.
  • Subjects must have no prior doxorubicin exposure.
  • No single lesion should be > 7 cm in maximum diameter.
  • Subjects must agree to receive no other systemic therapy from the time of study enrollment until a minimum of 21 days after their ThermoDox infusion

Who cannot join

  • Have serious medical illnesses including, but not limited to, congestive heart failure, myocardial infarction or cerebral vascular accident within the last six months, or life threatening cardiac arrhythmias.
  • Are pregnant or breast feeding. In women of childbearing potential, a negative pregnancy test (serum) is required at baseline, 1 month and each 3 month follow-up visit.
  • Are not practicing an acceptable form of birth control (i.e. diaphragm, cervical cap, condom, surgical sterility or birth control pills. Woman whose husband has undergone a vasectomy must use a second form of birth control).
  • Have known serious allergic reactions (anaphylaxis) to any of the drugs or liposomal components or imaging agents to be used in this study.
  • Have portal or hepatic vein invasion/thrombosis.
  • Have PT or PTT > 1.5 times the institution's upper normal limit (UNL), except in subjects who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation.
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  • Have platelet count > 75,000/mm3, absolute neutrophil count > 1500/mm3, or Hgb > 10 (unless the hemoglobin value has been stable, the subject is cardiovascularly stable, asymptomatic and judged able to withstand the RFA
  • Have serum creatinine ≤ 2.0 mg/dl (or calculated CrCl ≤ 60mL/min).
  • Have contraindications to receiving doxorubicin HCl.
  • Are being treated with other investigational agents (within a minimum of 30 days or 5 half-lives of the investigational agent).
  • Have other concurrent malignancy (subjects with benign or non aggressive malignant tumors-e.g.: squamous cell cancer of the skin-may be included), evidence of extrahepatic cancer from their primary malignancy, or ongoing, medically significant active infection.
  • Documented HIV positive.
  • NYHA class III or IV cardiovascular disease or LVEF < 50%.
  • Evidence of hemachromatosis.
  • Are on any of the medications listed in section 6.3, which could have an adverse effect when combined with the study drug, and who cannot stop the medication for the duration of the study and 30 days beyond the treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northshore Hospital - Long Island Jewish Health System

    Manhasset, New York, 11030

Other trials in United States

About this study

Official title: A Phase I Dose Escalation Tolerability Study of ThermoDox™ (Thermally Sensitive Liposomal Doxorubicin) in Combination With Radiofrequency Ablation (RFA) of Primary and Metastatic Tumors of the Liver

The purpose of this study is to determine the maximum tolerated dose (MTD) of ThermoDox when used in combination with radiofrequency ablation (RFA) in the treatment of primary and metastatic tumors of the liver.

Read the detailed description

Ablative treatment approaches, such as RFA or microwave ablation, have received increased attention as alternates to other treatment approaches such as hepatic arterial embolization or chemoembolization (TACE) or percutaneous ethanol injection (PEI) in the majority of patients who are either not candidates for surgical resection or are not offered palliative supportive care only for diffuse disease. RFA can be applied repetitively to the same patient to treat multiple tumors at time of diagnosis or upon tumor recurrence (local or distant to the site of ablation), and is largely limited in its application only by tumor location and size (tumors near larger vessels, bowel or the hepatobiliary tree are more difficult to ablate). To extend the volume of the ablation region in a controlled fashion in patients and to improve the ability to kill tumor cells in the ablation margin region and allow for the improved treatment of HCC and MLC lesions > 3 cm in diameter by complete thermal ablation, Celsion Corporation has developed ThermoDox, a thermally sensitive, intravenously administered liposomal formulation of doxorubicin capable of selectively releasing its drug contents when exposed to temperatures of > 39.5°C. The concept behind this treatment approach is to create a large concentration gradient of doxorubicin in the immediate region of the tumor which borders the zone of RFA induced cell necrosis. The temperature isotherms produced in this boundary region should be adequate to activate doxorubicin release by the thermally sensitive liposomes deposited locally around the ablation zone. This in effect increases the region of tissue that can be treated beyond that achievable by RFA alone. Several clinical objectives are being tested in this study. The MTD for ThermoDox is to be confirmed. This study will assess the safety of using ThermoDox in conjunction with RFA over multiple cycles, consistent with the clinical needs of the subjects. While this study is not powered to define effectiveness of the combination of RFA plus ThermoDox, the results of this study should allow for an assessment of risk and benefit for designing future studies. This study will also test alternative infusion reaction prophylaxis regimens.

Being tested
ThermoDox
Keywords
Radiofrequency ablation, RFA, Doxorubicin, Liposome, HCC, MLC, hepatocellular carcinoma, liver tumor, tumor, ablation, heat therapy, anti-tumor, liver cancer, metastatic liver cancer (MLC)
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms, Neoplasms, Hyperthermia

What participants receive

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

  • ThermoDoxDrug

    15 ml vial containing 2mg/ml Doxorubicin HCl, DPPC, MSPC, DSPE-MPEG 2000. Administered as single dose intravenously over 30 minutes. Dose is determined by dose cohort patient enters study.

Study groups in NCT00441376
Study groupRoleWhat they receive
ThermoDox + RFAExperimentalThermoDox administered as single dose intravenously over 30 minutes in combination with radiofrequency ablation. Dose is determined by dose cohort patient enters study.
Receives: Drug: ThermoDox

What is being measured

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

  1. To determine the maximum tolerated dose (MTD) of systemically delivered, heat-activated liposome encapsulated doxorubicin (ThermoDox) in combination with radiofrequency ablation (RFA) of liver neoplasms.

    Measured: 1 month

  2. To test alternative infusion reaction prophylaxis regimens

    Measured: 48 hours

  3. To assess the safety of ThermoDox plus RFA afer administration of potential multiple cycles

    Measured: 3 years

  4. To determine the Pharmacokinetics (PK) of ThermoDox

    Measured: 48 hours

Secondary outcomes (3)

  1. To document any anti-tumor activity and assess recurrences.

    Measured: 3 years

  2. To measure post ablation lesion volume.

    Measured: 1 month

  3. To determine the cardiotoxicity of ThermoDox through enhanced ECG monitoring.

    Measured: 48 hours

Timeline

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

  1. First posted28 Feb 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionOct 2008
  4. Study completionDec 2009

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00441376
Sponsor's protocol ID
104-06-101-01
Status last verified
Feb 2019
First submitted
26 Feb 2007
Last updated
7 Feb 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ThermoDox in people with Hepatocellular Carcinoma and Liver Neoplasms, run by Imunon at 1 site 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?

The sponsor lists 12 inclusion and 15 exclusion criteria. 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 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does the primary outcome measure?

To determine the maximum tolerated dose (MTD) of systemically delivered, heat-activated liposome encapsulated doxorubicin (ThermoDox) in combination with radiofrequency ablation (RFA) of liver neoplasms. (time frame: 1 month). The study lists 4 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 NCT00441376.

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 7 Feb 2019.

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