NCT00004248

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill liver cancer cells. PURPOSE: Phase II trial to study the effectiveness of doxorubicin and interleukin- 2 in treating patients who have liver cancer that cannot be removed by surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 1999

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

March 31, 2004

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

11 months

First QC Date

January 28, 2000

Last Update Submit

March 3, 2011

Conditions

Liver Cancer

Keywords

localized unresectable adult primary liver cancerrecurrent adult primary liver canceradult primary hepatocellular carcinoma

Interventions

aldesleukinBIOLOGICAL
doxorubicin hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven hepatocellular carcinoma OR Elevation of alpha fetoprotein (AFP) (greater than 400 ng/mL) in the presence of a space occupying lesion in the liver with known chronic liver disease Lesion must be easily biopsied Unresectable disease Bidimensionally measurable disease by radiography OR Evaluable disease with elevated AFP Okuda stage I disease Tumor size less than 50% of liver No ascites Albumin greater than 3 g/dL Bilirubin less than 2 mg/dL OR Okuda stage II disease Bilirubin as in stage I If ascites present, albumin must be greater than 3 g/dL PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9.0 g/dL Neutrophil count at least 1,500/mm3 Platelet count at least 80,000/mm3 Hepatic: See Disease Characteristics SGOT/SGPT no greater than 4 times upper limit of normal Any cause of underlying liver disease including hepatitis B or C allowed Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No poor cardiac function No myocardial infarction within the past 6 months No poorly controlled arrhythmia No congestive heart failure LVEF at least 45% by MUGA Other: No active hepatic encephalopathy No other active malignancies except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix HIV negative No immunodeficiency Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy, including interferon Chemotherapy: No prior systemic or intra arterial doxorubicin At least 6 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: At least 4 weeks since prior investigational therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

aldesleukinDoxorubicin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Lawrence P. Leichman, MD

    Albany Medical College

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2000

First Posted

March 31, 2004

Study Start

July 1, 1999

Primary Completion

June 1, 2000

Study Completion

May 1, 2001

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations

US(1)