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Thalidomide for Unresectable Hepatocellular Cancer With Optional Interferon Alpha-2a Upon Disease Progression


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

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Trial Information

Thalidomide for Unresectable Hepatocellular Cancer With Optional Interferon Alpha-2a Upon Disease Progression


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.

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Matthew D. Volm, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02347

NCT ID:

NCT00006006

Start Date:

August 2000

Completion Date:

Related Keywords:

  • Liver Cancer
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • Liver Neoplasms
  • Disease Progression

Name

Location

Mount Sinai School of MedicineNew York, New York  10029
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016