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

NCT00441376 | Completed Phase 1

• 1 other identifier: 104-06-101-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 the liver.

Conditions

Hepatocellular Carcinoma; Liver Neoplasms

Keywords

Radiofrequency ablation; RFA; Doxorubicin; Liposome; HCC; MLC; hepatocellular carcinoma; liver tumor; tumor; ablation; heat therapy; anti-tumor; liver cancer; metastatic liver cancer (MLC)

Outcome Measures

Primary Outcomes (4)

• 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.

  1 month

• To test alternative infusion reaction prophylaxis regimens

  48 hours

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

  3 years

• To determine the Pharmacokinetics (PK) of ThermoDox

  48 hours

Secondary Outcomes (3)

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

  3 years

• To measure post ablation lesion volume.

  1 month

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

  48 hours

Study Arms (1)

ThermoDox + RFA

EXPERIMENTAL

ThermoDox administered as single dose intravenously over 30 minutes in combination with radiofrequency ablation. Dose is determined by dose cohort patient enters study.

Drug: ThermoDox

Interventions

ThermoDox DRUG

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.

ThermoDox + RFA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imunon: lead

Study Sites (1)

Northshore Hospital - Long Island Jewish Health System

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Neoplasms; Hyperthermia

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2007
• First Posted: February 28, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2009
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

US (1)