NCT00054951

Brief Summary

MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick," to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and deposited in the area of a tumor, where it is thought that it then "leaks" through the blood vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes "free from" the magnetic beads and will then be able to act against the tumor cells. The iron component of the particle has magnetic properties making it possible to direct MTC-DOX to specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that MTC-DOX used with the magnet may target the chemotherapy directly to liver tumors and provide a treatment to patients with liver cancer. Patients enrolled in the study will be administered MTC-DOX through a hepatic artery catheter inserted under radiological guidance. During and following injection of the MTC-DOX, the drug will be localized to the hepatic tumor site by use of an external magnet. Dose may be divided in order to localize MTC-DOX to all lesions. The MTC-DOX intrahepatic infusions will be repeated every three weeks until tumor progression, complete remission, unacceptable toxicity, or a maximum of six treatment cycles. The purpose of this Phase 1/2 study is to evaluate time to disease progression following administration of MTC-DOX.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2003

Completed
Last Updated

June 24, 2005

Status Verified

September 1, 2003

First QC Date

February 13, 2003

Last Update Submit

June 23, 2005

Conditions

Hepatocellular Carcinoma

Keywords

HepatomaLiver Cancer

Interventions

MTC-DOX for InjectionDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has unresectable hepatocellular carcinoma diagnosed by CT scan and meets criteria described in Section 23.
  • Total combined cross-sectional area of all hepatic tumors as determined by CT scan is between 4 and 150 cm2.
  • The center of the tumor(s) mass must be less than or equal to 14 cm from the anterior lateral abdominal wall as determined by cross-sectional imaging at baseline. This is required for optimal placement of the magnet. If more than one tumor mass is present, all of the tumor masses must meet this criterion.
  • Patient is ambulatory with a Karnofsky performance status score greater than or equal to 60 and an estimated life expectancy of greater than or equal to 3 months.
  • Patient is between 18 and 80 years old.
  • Patient is judged by the investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to allow follow-up.
  • Patient or legal representative has the ability to give informed written consent prior to initiation of therapy.
  • If patient is female and of childbearing potential, she must have a negative b-HCG prior to receiving treatment.
  • Patient must agree to use an effective method of contraception (e.g., birth control pills, condoms, intrauterine device, diaphragm, Norplant, Depo-Provera).
  • Patients will be excluded from enrollment if any of the following apply:
  • Patient has a history of cancer other than hepatocellular (excluding resected basal cell carcinoma; or curatively resected stage 1 or less cervical cancer if disease free for 5 years or more).
  • Patient has had prior radiation therapy within the last 6 months or chemotherapy within the last 4 weeks.
  • Patients with diffuse hepatocellular carcinoma or disease that precludes delivery of the drug to the tumor via a vessel that feeds the tumor.
  • WBC \< 3,500/uL Platelets \< 40,000/ul Hemoglobin \< 9.5 gm/dL Total bilirubin \> 2.5 mg/dL ALT or AST \> or equal to 5 x upper limit of normal Serum Creatinine \> 2.0 mg/dL INR \> or equal to 2.0
  • Patient has cardiac dysfunction with a left ventricular ejection fraction \< 40%.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cancer Institute & Hosp. CAMS

Beijing, China

Location

Chinese PLA Cancer Ctr. Yang Gongjing

Nanjing, China

Location

Zhong Shan Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Joy Koda, Ph. D.

    VP Clinical Development

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 13, 2003

First Posted

February 17, 2003

Study Start

June 1, 2001

Last Updated

June 24, 2005

Record last verified: 2003-09

Locations

CN(3)