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



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

For Condition: recurrent adult primary liver cancer,localized unresectable adult primary liver cancer,advanced adult primary liver cancer,adult primary hepatocellular carcinoma
Status: No longer recruiting
Sponsor(s): Kaplan Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MatthewVolm,  Study Chair,  Kaplan Cancer Center

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City,  New York,  10016
United States
 

Mount Sinai School of Medicine
New York City,  New York,  10029
United States
 


Additional Information:
Study ID Numbers:  CDR0000068014;  NYU-9938,NCI-101
Study Start Date: 
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006006

Other Localized Unresectable Adult Primary Liver Cancer Studies:
1. Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction

2. Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer

3. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer

4. Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)

5. Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery

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