Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC

April 7, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

Phase I-II Clinical Trial of the Safety and Preliminary Efficacy of Hydroxychloroquine Combined With Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma

Primary Phase I:To determine dose limiting toxicities and maximum tolerated dose (MTD) of the oral administration of hydroxychloroquine (HCQ) in conjunction with transarterial chemoembolization (TACE) in treating hepatocellular carcinoma (HCC). A conventional 3+3 design will be utilized. Primary Phase II: To evaluate the complete response rate in a cohort of patients treated at the MTD, A Simon's Optimal Two-stage design will be utilized.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient capable of giving informed consent
  • Patient diagnosed with hepatocellular carcinoma in both lobes of the liver by one of the following methods (Pathologically confirmed HCC by biopsy or HCC 2 cm with classic radiographic findings of arterial phase enhancement with venous phase washout and pseudocapsule formation on contrast enhanced MRI or CT or Lesion greater than 2 cm with probable imaging features of HCC and imaging findings of cirrhosis and/or portal hypertension or a serum alphafetoprotein (AFP) greater than 200 mg/mL.
  • Patient not candidate for orthotopic liver transplantation at the Hospital of the University of Pennsylvania based on review of patient imaging and history at multidisciplinary Hepatic Tumor Conference at the Hospital of the University of Pennsylvania.
  • Age 18 years old
  • Albumin 2.4 g/dL; Total bilirubin 2 mg/dL; INR 1.5
  • Creatinine 2.0 mg/dL, AST 121 IU/L; ALT 189 IU/L
  • Child-Turcotte-Pugh Classification A or B
  • Eastern Clinical Oncology Group performance status 0 or1.

Exclusion Criteria:

  • Prior TACE
  • Active GI hemorrhage within 2 weeks of study enrollment
  • Ascites refractory to medical therapy
  • Contraindication to receiving HCQ or TACE
  • Unilobar HCC
  • Contraindication to contrast enhanced MRI (i.e. unable to undergo follow-up imaging)
  • Women who are pregnant
  • Participation in another concurrent treatment protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TACE + HCQ
Subjects will receive HCQ plus standard of care TACE.
Drug: HCQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 1 year
Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Gregory Nadolski, MD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 22213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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