Thalidomide Plus Interferon Alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed
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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. 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Biological: recombinant interferon alfa Drug: thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Thalidomide for Unresectable Hepatocellular Cancer With Optional Interferon Alpha-2a Upon Disease Progression |
| Enrollment: | 38 |
| Study Start Date: | August 2000 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Biological: recombinant interferon alfa Drug: thalidomide |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and 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 | |
| Study Chair: | Matthew D. Volm, MD | New York University School of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006006 History of Changes |
| Other Study ID Numbers: | NCI-2012-02347, NYU-9938, NCI-101, CDR0000068014 |
| Study First Received: | July 5, 2000 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 |
Additional relevant MeSH terms:
|
Liver Neoplasms Disease Progression Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Disease Attributes Pathologic Processes Interferon-alpha Interferon Alfa-2a Interferons Thalidomide Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013