RATIONALE: Heating tumors to several degrees above body temperature may kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of heat therapy in treating patients who have unresectable primary or metastatic liver cancer.

Condition	Treatment or Intervention	Phase
recurrent adult primary liver cancer stage III childhood liver cancer liver metastases advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent childhood liver cancer stage IV childhood liver cancer	Procedure: laparoscopic surgery  Procedure: laparotomy	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the efficacy of radiofrequency ablation in patients with primary or metastatic liver cancer.

II. Determine disease free survival, local recurrence rate in treated lesions as compared to known recurrence rates after hepatic cryoablation, and overall survival in this patient population receiving this regimen.

PROTOCOL OUTLINE:

Patients undergo laparoscopic or open laparotomy surgical procedure to identify unresectable tumors by ultrasound. Tumors are heated to a target temperature by electrodes for a maximum of 20 minutes. To acheive 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 may be retreated if tumor recurs or new disease appears.

Patients are followed at 1 month, every 3 months for the first 2 years, every 6 months for next 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 59 patients will be accrued for this study.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Diagnosis of unresectable malignant primary or metastatic liver tumors; Tumors are deemed unresectable based on the following factors: 1-10 liver tumors; Bilobar liver tumors; Location of 1 or more lesions near a major intrahepatic vascular structure (hepatic vein, portal vein, vena cava); Severe cirrhosis to preclude a major liver resection
• No unresectable extrahepatic disease
• Prior failure of other therapeutic modalities allowed
• No more than moderate ascites;No hepatic encephalopathy

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: At least 4 weeks since prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: At least 4 weeks since prior radiotherapy
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: Any age
• Performance status: Zubrod 0-1
• Life expectancy: At least 3 months
• Hematopoietic: Not specified
• Hepatic: No severe liver dysfunction (Child's Class C); Bilirubin no greater than 3.0 mg/dL; Albumin no greater than 3.0 mg/dL; PT no greater than 50% above normal
• Renal: No renal dysfunction; Creatinine less than 2.0 mg/dL
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No altered mental status; No active infection

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Steven A. Curley,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000067366; MDA-ID-97328; NCI-G99-1613
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004136
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08