- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006016
Thalidomide and Chemoembolization With Doxorubicin in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
An Evaluation of Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
I. Determine the feasibility and potential activity of thalidomide in patients with unresectable hepatocellular carcinoma who are undergoing chemoembolization to predominant tumor masses.
II. Determine the toxicity of this regimen of these patients. III. Determine the overall survival of patients treated with this regimen. IV. Determine the serum levels of vascular endothelial growth factor, basic fibroblast growth factor, and tumor necrosis factor alpha in patients treated with this regimen.
OUTLINE:
Patients receive oral thalidomide daily beginning 4 weeks before the first planned chemoembolization procedure. Thalidomide administration is stopped 24 hours before each chemoembolization procedure, and then restarted at 24 hours after completion of each procedure OR when blood counts and levels of bilirubin and transaminases recover, whichever occurs later. Thalidomide treatment continues in the absence of disease progression or unacceptable toxicity.
Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only under angiographic guidance. Immediately after delivery of the chemoemulsion, patients undergo particulate embolization. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe. Patients are reevaluated for repeat chemoembolization within 8-12 weeks of the last chemoembolization. For eligible patients, each lobe is treated separately a second time, in the same sequence, in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 18 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University Langone Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically proven hepatocellular carcinoma
- Ineligible for potentially curative surgical resection
Must be a candidate for palliative chemoembolization
MRI must show one or more discrete tumor nodules that can be targeted by angiography for chemoembolization
- No diffusely infiltrating tumor
- Lesions under consideration for chemoembolization must demonstrate substantial hypervascularity
- Performance status - ECOG 0-2
- Absolute neutrophil count at least 1,200/mm^3
- Hemoglobin at least 8.0 g/dL
- Platelet count at least 50,000/mm^3
- SGOT and SGPT no greater than 5 times normal
- Bilirubin less than 3 mg/dL
- Creatinine no greater than 1.5 mg/dL
- No other medical condition that would preclude study participation
- No other malignancy within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
Regardless of fertility status:
- All female patients (unless they have undergone a 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 participation
- All male patients (even if they have undergone a successful vasectomy) must use effective barrier contraception during and for at least 4 weeks after study participation
- Prior interferon for hepatitis allowed
- No prior biologic therapy for hepatocellular carcinoma (HCC)
- No prior chemotherapy for hepatocellular carcinoma (HCC)
- No concurrent barbiturates or alcohol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment (thalidomide, chemoembolization)
Patients receive oral thalidomide daily beginning 4 weeks before the first planned chemoembolization procedure.
Thalidomide administration is stopped 24 hours before each chemoembolization procedure, and then restarted at 24 hours after completion of each procedure OR when blood counts and levels of bilirubin and transaminases recover, whichever occurs later.
Thalidomide treatment continues in the absence of disease progression or unacceptable toxicity.
Patients undergo placement of a visceral arterial catheter.
Patients receive doxorubicin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only under angiographic guidance.
Immediately after delivery of the chemoemulsion, patients undergo particulate embolization.
The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe.
Patients are reevaluated for repeat chemoembolization within 8-12 weeks of the last chemoembolization.
|
Correlative studies
Given orally
Other Names:
Given transarterially (chemoembolization)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival
Time Frame: Up to 18 months
|
The survival distribution will be estimated using the Kaplan-Meier method, with corresponding 95% confidence intervals.
|
Up to 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alec Goldenberg, NYU Langone Health
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study 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
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Carcinoma, Hepatocellular
- Liver Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Antibiotics, Antineoplastic
- Thalidomide
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- NCI-2012-02352 (REGISTRY: CTRP (Clinical Trial Reporting Program))
- 99 (CTEP)
- N01CM17103 (U.S. NIH Grant/Contract)
- NCI-99
- CDR0000068025
- NYU-9937 (OTHER: New York University Langone Medical Center)
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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