Know Cancer

or
forgot password

The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer, Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms


OBJECTIVES:

- Evaluate the nature and duration of response of patients with primary or metastatic
liver neoplasms, who are not candidates for surgical resection, treated with
radiofrequency interstitial tissue ablation.

- Evaluate the ability of dynamic magnetic resonance imaging (MRI) to assess the effects
of this therapy on tumor blood flow and tumor vascular density in these patients.

- Determine the ability of positron emission tomography with fludeoxyglucose F 18
(FDG-PET) to monitor response after treatment with this therapy in these patients.

- Compare FDG-PET results with CT scan, biopsy, and serum marker results in patients
treated with this therapy.

- Compare the performance of FDG-PET with CT scan and MRI, in terms of their ability to
assess the efficacy of this therapy in these patients.

OUTLINE: Lesions are targeted by ultrasound and then radiofrequency ablation needles are
inserted into the lesions and heated to a target temperature greater than 60 degrees C for
15 minutes, though exposure time may vary depending on temperatures achieved. To achieve a 1
cm margin of ablated tissue around each lesion, multiple ablation courses may be performed,
depending on the size of the lesions and the time required to complete the treatment.

Patients undergo magnetic resonance imaging with gadopentetate dimeglumine contrast, CT
scan, ultrasound, and positron emission tomography with fludeoxyglucose F 18 at baseline, 6
weeks, every 3 months for 1 year, and then every 6 months for 2 years.

Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months for 2
years or until evidence of recurrence.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study within 6 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary or metastatic liver lesions

- Not a candidate for surgical resection

- Must have six or fewer lesions and no single lesion greater than 7 cm in diameter

- Extrahepatic disease allowed

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Platelet count at least 50,000/mm^3

- PT or PTT no greater than 1.5 times control (except for therapeutically
anticoagulated nonrelated medical conditions [e.g., atrial fibrillation])

Hepatic:

- Bilirubin no greater than 3.0 mg/dL

Renal:

- Creatinine no greater than 2.5 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- No pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic
devices

- No known uncontrollable serious reactions (e.g., anaphylaxis) to contrast agents used
in this study

- Weight less than 136 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- Concurrent systemic therapy for extrahepatic disease is allowed only if begun prior
to radiofrequency ablation

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Nature and duration of response

Safety Issue:

No

Principal Investigator

Steven K. Libutti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Food and Drug Administration

Study ID:

990025

NCT ID:

NCT00019604

Start Date:

August 1998

Completion Date:

Related Keywords:

  • Liver Cancer
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • liver metastases
  • unspecified adult solid tumor, protocol specific
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182