An Evaluation of Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer

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Trial Information

An Evaluation of Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Outcome Description:

The survival distribution will be estimated using the Kaplan-Meier method, with corresponding 95% confidence intervals.

Outcome Time Frame:

Up to 18 months

Safety Issue:

No

Principal Investigator

Alec Goldenberg

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University Langone Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02352

NCT ID:

NCT00006016

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Adult Primary Hepatocellular Carcinoma
  • Advanced Adult Primary Liver Cancer
  • Localized Unresectable Adult Primary Liver Cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location
New York University Langone Medical Center New York, New York  10016