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
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Neoplasms; Neoplasm Metastasis
Intervention: Isolated hepatic portal and arterial perfusion (Procedure); Melphalan (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: National Cancer Institute (NCI)
Summary
Patients with unresectable primary or metastatic cancer confined to the liver will undergo a
1 hour hyperthermic isolated hepatic perfusion (IHP) via the portal vein and hepatic artery
with escalating dose melphalan. Patients eligible for this protocol are those with
non-colorectal histologies and those with colorectal cancer previously treated with
intra-arterial FUDR. Hepatic and systemic toxicity, response to treatment, duration of
response, and survival will be followed.
Clinical Details
Official title: 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
Study design: Treatment, Safety Study
Detailed description:
Patients with unresectable primary or metastatic cancer confined to the liver will undergo a
1 hour hyperthermic isolated hepatic perfusion (IHP) via the portal vein and hepatic artery
with escalating dose melphalan. Patients eligible for this protocol are those with
non-colorectal histologies and those with colorectal cancer previously treated with
intra-arterial FUDR. Hepatic and systemic toxicity, response to treatment, duration of
response, and survival will be followed.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
National Cancer Institute (NCI), Bethesda, Maryland 20892, United States
Additional Information
Related publications: Alexander HR Jr, Bartlett DL, Libutti SK. Isolated hepatic perfusion: a potentially effective treatment for patients with metastatic or primary cancers confined to the liver. Cancer J Sci Am. 1998 Jan-Feb;4(1):2-11. Review. No abstract available. Alexander HR Jr, Bartlett DL, Libutti SK, Fraker DL, Moser T, Rosenberg SA. Isolated hepatic perfusion with tumor necrosis factor and melphalan for unresectable cancers confined to the liver. J Clin Oncol. 1998 Apr;16(4):1479-89.
Starting date: September 1997
Ending date: March 2001
Last updated: July 12, 2006
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