Status:
COMPLETED
A Study of ThermoDox™ in Combination With Radiofrequency Ablation (RFA) in Primary and Metastatic Tumors of the Liver
Lead Sponsor:
Imunon
Conditions:
Hepatocellular Carcinoma
Liver Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
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 chemoembolizati...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00441376
Start Date
February 1 2007
End Date
December 1 2009
Last Update
February 7 2019
Active Locations (1)
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1
Northshore Hospital - Long Island Jewish Health System
Manhasset, New York, United States, 11030