Liver Cancer
A Phase II Study of Hepatic Arterial Infusion of Melphalan With Venous Filtration via Peripheral Hepatic Perfusion (PHP) for Unresectable Primary and Metastatic Cancers of the Liver
NCI-04-C-0273
Print this page 
Investigator(s): |
Marybeth S. Hughes, M.D.
Principal Investigator
Phone: 301-594-9341
hughesm@mail.nih.gov
|
|
|
|
Carole Webb, R.N.
Research Nurse
Phone: 301-451-6940
Webbcc@mail.nih.gov
|
Bryan Emery, R.N.
Research Nurse
Phone: 301-451-6940
eemery@mail.nih.gov
|
|
| |
Primary Eligibility:
- Histologically or cytologically confirmed hepatic malignancy (adenocarcinoma of gastrointestinal origin, neuroendocrine tumor, or primary hepatic malignancy)
- Unresectable disease predominantly in the liver
- Hepatic metastasis from colorectal tumors allowed provided patient has undergone second-line chemotherapy, including CPT-11 and oxaliplatin
- Limited unresectable extra hepatic disease allowed if life-limiting component of progressive disease is in the liver
- Prior IHP or PHP allowed provided the patient had a radiographic response of 3 months after therapy
- Adequate hepatic function; total serum bilirubin ≤ 2.0 mg/dL; PT within 2 seconds of the upper normal limit; AST/ALT must be ≤ 10 times upper limit of normal
- No Childs class B or C cirrhosis, portal hypertension, congestive heart failure, COPD, severe allergic reaction to iodine contrast, or hypersensitivity to melphalan
Treatment Plan:
- Patients are stratified according to primary tumor histology (neuroendocrine tumor vs. primary hepatic malignancy vs. adenocarcinoma of gastrointestinal or other origin)
- Patients undergo peripheral isolated hepatic perfusion in which a catheter is placed via the groin into the hepatic artery and another into the hepatic vein
- Patients then receive melphalan as an intrahepatic arterial infusion over 15–30 minutes
- Treatment repeats approximately every 3–8 weeks for up to 4 total infusions in the absence of disease progression or unacceptable toxicity
- Patients are followed every 3 months for 2 years, every 4 months for 1 year, and then periodically thereafter
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 12/4/08
Updated: 11/13/08
Back to Top
