Thalidomide Plus Interferon Alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed

NCT ID: NCT00006006

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31

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.

Detailed Description

OBJECTIVES:

I. Determine the feasibility and activity of thalidomide in patients with unresectable hepatocellular carcinoma.

II. Evaluate the toxicity of thalidomide in these patients. III. Assess the use of interferon alfa in patients who develop disease progression while being treated with thalidomide.

OUTLINE: This is a multicenter study.

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.

Conditions

Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

recombinant interferon alfa

Intervention Type: BIOLOGICAL

thalidomide

Intervention Type: DRUG

Interventions

recombinant interferon alfa

Intervention Type: BIOLOGICAL

thalidomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew D. Volm, MD

Role: STUDY_CHAIR

NYU Langone Health

Locations

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 16249352 (View on PubMed)

Other Identifiers

NYU-9938

Identifier Type: -

Identifier Source: secondary_id

NCI-101

Identifier Type: -

Identifier Source: secondary_id

CDR0000068014

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02347

Identifier Type: -

Identifier Source: org_study_id