Trial record 7 of 11 for:    celsion

Study of ThermoDox With Standardized Radiofrequency Ablation (RFA) for Treatment of Hepatocellular Carcinoma (HCC) (OPTIMA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Celsion
Sponsor:
Information provided by (Responsible Party):
Celsion
ClinicalTrials.gov Identifier:
NCT02112656
First received: April 10, 2014
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when used in conjunction with standardized radiofrequency ablation (sRFA).


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: ThermoDox
Drug: Dummy infusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double Blind, Dummy-Controlled Study of ThermoDox® (Lyso-Thermosensitive Liposomal Doxorubicin-LTLD) in Hepatocellular Carcinoma (HCC) Using Standardized Radiofrequency Ablation (RFA) Treatment Time ≥ 45 Minutes for Solitary Lesions ≥ 3 cm to ≤ 7 cm

Resource links provided by NLM:


Further study details as provided by Celsion:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Overall survival is defined as the time (in months) from the date of randomization to the death date.


Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Progression-free survival is defined as the time (in months) from the date of randomization until the date of the Investigator-assessed radiological disease progression or death due to any cause.


Estimated Enrollment: 550
Study Start Date: June 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ThermoDox 50 mg/m2
ThermoDox plus standardized RFA using standardized treatment dwell time for solitary HCC lesions ≥ 3.0 cm to ≤ 7.0 cm
Drug: ThermoDox
Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
Placebo Comparator: Dummy infusion
standardized RFA alone using standardized treatment dwell time for solitary HCC lesions ≥ 3.0 cm to ≤ 7.0 cm
Drug: Dummy infusion
Sodium Chloride 0.9% or 5% Dextrose (D5W), Single 30 minute intravenous infusion

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥ 18 years of age.
  2. Diagnosed with a single HCC lesion ≥ 3.0 cm but ≤ 7.0 cm in maximum diameter based on diagnosis at screening.

    • Subjects meeting the American Association for the Study of Liver Disease (AASLD) criteria may be randomized without a biopsy, but will undergo a biopsy during the RFA procedure unless contraindicated or unattainable.
    • Subjects not meeting the AASLD criteria for HCC will need a biopsy to confirm HCC prior to randomization.
  3. Be an appropriate candidate for receiving RFA as a medically indicated treatment as evaluated by the following factors:

    • The position and accessibility of the target lesion allows for the safe administration of multiple ablation cycles or deployments to achieve a probe dwell time of ≥ 45 minutes.
    • Not a candidate for surgical resection according to the local guidelines for resection and in the Investigator's judgment.
  4. Child-Pugh Class A without either current encephalopathy or ascites.
  5. Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0.
  7. Willing to sign an informed consent form, indicating awareness of the investigational nature of this study that is in keeping with the policies of the institution.

Exclusion Criteria:

  1. Is scheduled for liver transplantation
  2. Expected ablation volume > 30% of total liver volume or removal of 3 hepatic segments
  3. More than 1 lesion identified during baseline.
  4. Have previously received therapeutic treatment for HCC outside the study protocol or is expected to receive concomitant HCC treatment prior to PFS event.
  5. 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.
  6. Have previously received any anthracycline outside the protocol
  7. Have extrahepatic metastasis.
  8. Have portal or hepatic vein tumor invasion/thrombosis.
  9. Have body temperature >101ºF (38.3ºC) immediately prior to study treatment.
  10. Baseline laboratories (repeat lab tests are permitted to evaluate eligibility during the Screening Period. Lab results must be within protocol range prior to study treatment.)

    • Absolute neutrophil count < 1500/mm3
    • Platelet count < 75,000/mm3
    • Hgb < 10.0 g/dL (unless the hemoglobin value has been stable, the subject is cardiovascularly stable, asymptomatic and judged able to withstand the RFA procedure) Note: If clinically indicated, subjects may receive platelets or packed red blood cell (RBC) transfusions and be re-evaluated after condition is treated.
  11. Baseline Chemistry

    • Serum creatinine ≥ 2.5 mg/dL or calculated creatinine clearance (CrCl) ≤25.0 mL/min.
    • Serum bilirubin > 3.0 mg/dL.
    • Serum albumin < 2.8 g/dL.
  12. Have any known allergic reactions to any of the drugs or liposomal components or intravenous imaging agents that prohibit the ability to complete the imaging requirements.
  13. Are pregnant or breast-feeding. In women of childbearing potential, a negative serum pregnancy test is required prior to study treatment.
  14. Women of childbearing potential and men who are not practicing an acceptable form of birth control (i.e. diaphragm, cervical cap, condom, surgical sterility or birth control pills. Women whose partner has or men who have undergone a vasectomy must use a second form of birth control).
  15. Have INR > 1.5 times the institution's upper normal limit (UNL), except in subjects who are therapeutically anticoagulated for medical conditions unrelated to HCC such as atrial fibrillation. Subjects may be re-screened after condition is treated or anticoagulant is withheld.
  16. Have contraindications to receiving doxorubicin hydrochloride (HCl).
  17. Are being treated with other investigational agents.
  18. Use of an investigational drug outside this study within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.
  19. Have other concurrent malignancy (subjects with treated squamous cell carcinoma of the skin or basal cell carcinoma of the skin may be included), evidence of extrahepatic cancer from their primary malignancy, or ongoing, medically significant active infection.
  20. HIV positive.
  21. NYHA class III or IV functional classification for heart failure.
  22. Evidence of hemachromatosis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112656

  Show 50 Study Locations
Sponsors and Collaborators
Celsion
Investigators
Principal Investigator: Ricardo Lencioni, MD University of Pisa
Principal Investigator: Ronnie T. Poon, M.D. Queen Mary Hospital, Hong Kong
Principal Investigator: Chen Min Hua, M.D. Beijing University Cancer Hospital
  More Information

No publications provided

Responsible Party: Celsion
ClinicalTrials.gov Identifier: NCT02112656     History of Changes
Other Study ID Numbers: 104-13-302
Study First Received: April 10, 2014
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration
Korea: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada

Keywords provided by Celsion:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antibiotics, Antineoplastic
Doxorubicin
Liposomal doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014