Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)

NCT01116635 | Completed Phase 1

• 1 other identifier: H08-02833
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to determine whether loading doxorubicin (a type of chemotherapy), when loaded onto a drug eluting microsphere will result in increased destruction of a tumor. The study will treat patients with surgically resectable liver cancers with varying doses of doxorubicin loaded into microspheres, with a close review of any side effects and chemotherapy concentrations in the bloodstream. The tumors will be surgically removed after at least 1 month, to determine how much the tumor has shrunk, and the amount of tumor destroyed. It is hoped that the study results will determine if this treatment has a role in controlling tumor growth prior to surgical removal.

Conditions

Hepatocellular Carcinoma

Keywords

chemoembolization; drug eluting microsphere; hepato; embolotherapy; downstage

Outcome Measures

Primary Outcomes (1)

• Histopathological correlation with surgically resected tumor

Secondary Outcomes (3)

• Dose limiting toxicities

• serum doxorubicin release patter

• maximum tolerated dose

Study Arms (2)

50mg dose loading per vial of doxorubicin

EXPERIMENTAL

Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy

75mg dose loading per vial of doxorubicin

EXPERIMENTAL

Drug: doxorubicin, superabsorbent polymer microspheres, embolotherapy

Interventions

doxorubicin, superabsorbent polymer microspheres, embolotherapy DRUG

varying doses of doxorubicin loaded onto SAP during embolization procedure. Pharmacokinetic analysis of elution profile through serum concentrations over 1 month period embolization of surgically resectable HCC with superabsorbent polymer microspheres loaded with doxorubicin from a single treatment. Phase I will follow a modified Fibonacci sequence (with pharmacokinetic analysis of serum doxorubicin) to determine mean tolerated dose (MTD), severe adverse reaction (SAE) and dose limiting toxicities (DLT) when microspheres are loaded with 25mg, 50mg, or 75mg of doxorubicin. Phase II will continue enrollment with the two highest tolerated doses. At least one month after treatment, all patients will undergo imaging and surgical resection of reference tumor, with assessment of degree of necrosis, microsphere distribution, and correlation with concentration of doxorubicin loaded onto microsphere.

Also known as: chemoembolization, drug eluting bead, drug eluting microsphere, superabsorbent microsphere, radioembolization, bland embolization

50mg dose loading per vial of doxorubicin; 75mg dose loading per vial of doxorubicin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• Klass D, Owen D, Buczkowski A, Chung SW, Scudamore CH, Weiss AA, Yoshida EM, Ford JA, Ho S, Liu DM. The effect of doxorubicin loading on response and toxicity with drug-eluting embolization in resectable hepatoma: a dose escalation study. Anticancer Res. 2014 Jul;34(7):3597-606.

  PMID: 24982375 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Doxorubicin; Embolization, Therapeutic; Chemoembolization, Therapeutic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Stephen Chung, MD

  University of British Columbia

  STUDY DIRECTOR

• Jo-Ann Ford, RN

  University of British Columbia

  STUDY DIRECTOR

• Sharlene Gill, MD

  University of British Columbia

  STUDY DIRECTOR

• Stephen Ho, MD

  University of British Columbia

  STUDY DIRECTOR

• David Owen, MD

  University of British Columbia

  STUDY DIRECTOR

• Charles Scudamore, MD

  University of British Columbia

  STUDY DIRECTOR

• Ellen Wasan, PhD

  University of British Columbia

  STUDY DIRECTOR

• Alan Weiss, MD

  University of British Columbia

  STUDY DIRECTOR

• Eric Yoshida, MD

  University of British Columbia

  STUDY DIRECTOR

• Sigfried Erb, MD

  University of British Columbia

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

CA (1)