Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.
  PURPOSE: This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with primary unresectable liver cancer or liver metastases.

Detailed description: OBJECTIVES:
  -  Determine response rate, duration of response, and patterns of recurrence in patients with primary or metastatic, unresectable cancers of the liver after treatment with isolated hepatic perfusion with melphalan.
  -  Determine the disease-free and overall survival of patients treated with this regimen.
  OUTLINE: Patients who are otherwise eligible undergo an exploratory laparotomy of the peritoneal cavity. Patients with peritoneal seeding, unresectable extrahepatic metastases, or unresectable pathologically-involved lymph nodes outside area of portahepatis do not receive treatment. Remaining patients receive isolated hepatic perfusion with melphalan. Liver perfusion proceeds for 1 hour.
  Patients are followed at 6 weeks, every 3 months for 2 years, and then every 4 months until disease progression.
  PROJECTED ACCRUAL: A maximum of 67 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically proven liver cancer meeting 1 of the following criteria:
  -  Primary unresectable hepatocellular or cholangiocellular carcinoma
  -  Metastatic cancer to the liver originating from one of the following:
  -  Intraocular melanoma (closed to accrual as of 10/17/03)
  -  Islet cell carcinoma
  -  Adenocarcinoma of the colon or rectum limited to parenchyma of the liver
  -  No evidence of other unresectable extrahepatic colorectal metastasis
  -  Other neuroendocrine tumors, such as carcinoid tumors
  -  Measurable disease
  PATIENT CHARACTERISTICS:
  Age:
  -  Any age
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Platelet count greater than 100,000/mm^3
  -  Hematocrit greater than 27.0%
  -  WBC at least 2,500/mm^3
  Hepatic:
  -  Bilirubin less than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)
  -  PT no greater than 2 seconds above upper limit of normal
  -  Elevated SGOT and SGPT allowed if not due to hepatitis
  -  No biopsy-proven cirrhosis or evidence of significant portal hypertension
  -  No prior or concurrent veno-occlusive disease
  -  Patients with positive hepatitis B or C surface antigen serology and chronic active hepatitis are eligible provided there is no evidence of cirrhosis
  Renal:
  -  Creatinine no greater than 1.5 mg/dL OR
  -  Creatinine clearance greater than 60 mL/min
  Cardiovascular:
  -  Congestive heart failure allowed if LVEF ≥ 40%
  Pulmonary:
  -  No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function tests less than 50% predicted for age
  Other:
  -  Weight greater than 30 kg
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  No active infection
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 1 month since prior anticancer biologic therapy and recovered
  Chemotherapy:
  -  At least 1 month since prior anticancer chemotherapy and recovered
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  At least 1 month since prior anticancer radiotherapy and recovered
  Surgery:
  -  Not specified
  Other:
  -  Prior intrahepatic arterial infusion therapy allowed
  -  No chronic use of anticoagulants
  -  No concurrent immunosuppressive therapy

Relevance to patient case: not relevant