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Thalidomide Plus Interferon Alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed
This study has been completed.
First Received: July 5, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: New York University School of Medicine
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006006
  Purpose

RATIONALE: 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.

PURPOSE: 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.


Condition Intervention Phase
Liver Cancer
Biological: recombinant interferon alfa
Drug: thalidomide
Phase II

MedlinePlus related topics: Cancer Liver Cancer Surgery
Drug Information available for: Thalidomide Interferon alfa-2a Interferon alfa-n1 Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Thalidomide for Unresectable Hepatocellular Cancer With Optional Interferon Alpha-2a Upon Disease Progression

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2000
Detailed Description:

OBJECTIVES:

  • Determine the feasibility and activity of thalidomide in patients with unresectable hepatocellular carcinoma.
  • Evaluate the toxicity of thalidomide in these patients.
  • 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.

PROJECTED ACCRUAL: A total of 29-38 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Life expectancy:

  • Not specified

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

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent barbiturates or alcohol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006006

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Chair: Matthew D. Volm, MD New York University School of Medicine
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068014, NYU-9938, NCI-101
Study First Received: July 5, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00006006     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized unresectable adult primary liver cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

Study placed in the following topic categories:
Interferon-alpha
Interferon Type I, Recombinant
Liver Diseases
Digestive System Neoplasms
Immunologic Factors
Thalidomide
Carcinoma, Hepatocellular
Interferons
Disease Progression
Immunosuppressive Agents
Angiogenesis Inhibitors
Antiviral Agents
Recurrence
Carcinoma
Liver Neoplasms
Anti-Bacterial Agents
Digestive System Diseases
Gastrointestinal Neoplasms
Hepatocellular Carcinoma
Interferon Alfa-2a

Additional relevant MeSH terms:
Anti-Infective Agents
Interferon Type I, Recombinant
Liver Diseases
Immunologic Factors
Thalidomide
Antineoplastic Agents
Physiological Effects of Drugs
Liver Neoplasms
Anti-Bacterial Agents
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Interferon-alpha
Digestive System Neoplasms
Growth Substances
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Interferon Alfa-2a
Leprostatic Agents

ClinicalTrials.gov processed this record on May 06, 2009