NCT00006006

Brief Summary

Phase II trial to study the effectiveness of thalidomide plus interferon alfa in treating patients who have progressive liver cancer that cannot be surgically removed. Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of the cancer cells. Combining thalidomide and interferon alfa may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 5, 2000

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Last Updated

February 11, 2013

Status Verified

September 1, 2003

Enrollment Period

4.6 years

First QC Date

July 5, 2000

Last Update Submit

February 8, 2013

Conditions

Liver Cancer

Keywords

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

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral thalidomide once daily. Patients on a stable dose of thalidomide for at least 4 weeks with evidence of progressive disease receive interferon alfa subcutaneously twice daily. Treatment continues in the absence of disease progression after initiation of interferon alfa therapy or unacceptable toxicity.

Biological: recombinant interferon alfaDrug: thalidomide

Interventions

recombinant interferon alfaBIOLOGICAL
Arm I
thalidomideDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed hepatocellular carcinoma OR * Diagnosis of hepatocellular carcinoma based on characteristic mass and alpha-fetoprotein greater than 500 in the setting of known cirrhosis or chronic hepatitis B or C * Measurable disease * At least 20 mm in one dimension * Not amenable to curative surgical resection PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Hematopoietic: * Absolute neutrophil count greater than 1,200/mm\^3 * Hemoglobin at least 8.0 mg/dL * Platelet count at least 25,000/mm\^3 Hepatic: * Bilirubin no greater than 5 mg/dL * Liver function tests no greater than 5 times normal Renal: * Creatinine no greater than 1.5 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Regardless of fertility status: * All women (unless they have undergone hysterectomy or have been amenorrheic or postmenopausal for at least 2 years) must use at least 1 highly active method of contraception AND 1 additional effective method of contraception at least 4 weeks before, during, and for at least 4 weeks after study * All men (even if they have undergone a successful vasectomy) must use effective barrier contraception during and for at least 4 weeks after study * No other medical condition that would preclude study * No other prior malignancy in past 5 years except curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 1 prior biologic therapy regimen * No prior interferon or thalidomide for hepatocellular cancer Chemotherapy: * No more than 1 prior chemotherapy regimen Other: * No concurrent barbiturates or alcohol

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

Sponsors & Collaborators

Study Sites (2)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (1)

  • Schwartz JD, Sung M, Schwartz M, Lehrer D, Mandeli J, Liebes L, Goldenberg A, Volm M. Thalidomide in advanced hepatocellular carcinoma with optional low-dose interferon-alpha2a upon progression. Oncologist. 2005 Oct;10(9):718-27. doi: 10.1634/theoncologist.10-9-718.

    PMID: 16249352RESULT

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

Interferon-alphaThalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Matthew D. Volm, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

August 1, 2000

Primary Completion

March 1, 2005

Last Updated

February 11, 2013

Record last verified: 2003-09

Locations

US(2)