A Phase I Study of Isolated Hepatic Portal and Arterial Perfusion (IHP) With Escalating Dose Melphalan for Primary or Metastatic Unresectable Cancers of the Liver

Inclusion Criteria

Histologically or cytologically proven measurable primary or metastatic non-colorectal
cancer limited to the parenchyma of the liver with no evidence of unresectable
extrahepatic disease by preoperative radiological studies.

Limited resectable extrahepatic disease is acceptable.

Patients with colorectal cancer previously treated with intrahepatic arterial infusional
therapy using FUDR, those with aberrant arterial anatomy such that infusional therapy is
not possible, or those with limited extrahepatic disease such that regional therapy is not
indicated will be eligible for this protocol.

Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their
malignancy in the month prior to the liver perfusion and must have recovered from all side
effects.

Patients must have an ECOG performance standard of 0, 1 or 2 on the day prior to
treatment.

Patients must have adequate hepatic function as evidence by bilirubin less than 2.0 and a
PT and PTT that are within 1-2 seconds of the upper normal limit.

No patients with biopsy proven cirrhosis or evidence of significant portal hypertension by
history, endoscopy, or radiologic studies will be included.

No patients with a history of congestive heart failure with an LVEF of equal to or less
than 40% will be included.

No patients with COPD or other chronic pulmonary disease with PFT's less than 50%
predicted for age will be included.

Patients must be 18 years of age or older.

Patients must have a platelet count greater than 100,000, a HCT greater than 27.0, a white
blood count greater than 3000/ micrograms, and a creatinine less than or equal to 1.5 or a
creatinine clearance of greater than 60 ml/min.

No pregnant patients or nursing mothers will be eligible.

Patients must not be taking immunosuppressive drugs or on chronic anticoagulation.

Patients must not have an active infection.

Patients with severe allergic reactions to iodine contrast which can not be controlled by
premedication with antihistamines and steroids are not eligible as a hepatic angiogram is
needed for this procedure.

Patients must not have HIV disease.

Patients must be aware of the neoplastic nature of his/her illness, the experimental
nature of the therapy, alternative treatments, potential benefits, and risks.

The patient must be willing to sign an informed consent.

Patients must not have a history of veno occlusive disease.