- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006006
Thalidomide Plus Interferon Alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed
Thalidomide for Unresectable Hepatocellular Cancer With Optional Interferon Alpha-2a Upon Disease Progression
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Matthew D. Volm, MD, NYU Langone Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Interferons
- Interferon-alpha
- Thalidomide
Other Study ID Numbers
- NCI-2012-02347
- NYU-9938
- NCI-101
- CDR0000068014 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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