Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
This is a clinical trial to test the safety and efficacy of the drug thalidomide in combination with a procedure called chemoembolization in patients with inoperable liver cancer. Chemoembolization is the process by which chemotherapy is instilled directly into the blood vessels feeding the tumor, so that the blood vessels feeding the tumor may be blocked. Chemoembolization consists of two separate procedures. It will be done by infusing chemotherapy with the drug doxorubicin through the hepatic artery into the liver and then by infusing collagen to cut off the blood supply to the tumor. A catheter will be inserted at various times to allow for these infusions. The objectives are to investigate the feasibility and potential activity of chronic administration of thalidomide in patients with unresectable hepatocellular cancer who receive chemoembolization to predominant tumor masses. The toxicity of thalidomide in these patients will be evaluated. Overall safety will also be assessed. Serum levels of angiogenic cytokines such as VEGF, bFGF, and TNF-a, that are believed to have a role in hepatocellular carcinoma, will be collected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2000
CompletedFirst Posted
Study publicly available on registry
September 11, 2000
CompletedJune 24, 2005
January 1, 2004
September 9, 2000
June 23, 2005
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Patients with unresectable hepatocellular carcinoma.
- MRI of liver must show discrete tumor nodules. Lesions on angiography must be hypervascular.
- Patient must have the following minimum labs: ANC\> 1200/mm3; Hemoglobin \> 8 mg/dl; platelets \> 50,000 mm3; hepatic transaminases \< 5x normal; bilirubin \< 3.0 mg/dl; and creatinine \< 1.5 mg/dl.
- ECOG performance status \> 2.
- No history of prior chemotherapy or biologic therapy for hepatocellular carcinoma.
- No other history of malignancy other than curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Patients must not be pregnant or lactating.
- Sexually active men and women of childbearing age must use adequate contraception. All patients must understand the potential for severe birth defects with thalidomide and must be able to follow instructions to avoid conception while taking thalidomide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaplan Comprehensive Cancer Center
New York, New York, 10016, United States
Related Publications (1)
Wu J, Ng J, Christos PJ, Goldenberg AS, Sparano J, Sung MW, Hochster HS, Muggia FM. Chronic thalidomide and chemoembolization for hepatocellular carcinoma. Oncologist. 2014 Dec;19(12):1229-30. doi: 10.1634/theoncologist.2014-0283. Epub 2014 Oct 31.
PMID: 25361625DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 9, 2000
First Posted
September 11, 2000
Last Updated
June 24, 2005
Record last verified: 2004-01