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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00096083 |
Purpose
RATIONALE: Hepatic arterial infusion uses a catheter to deliver anticancer substances directly into the liver. Drugs used in chemotherapy, such as melphalan, work in 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 giving an hepatic arterial infusion of melphalan together with hepatic perfusion works in treating patients with unresectable liver cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: isolated perfusion Drug: melphalan |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | 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 |
| Estimated Enrollment: | 105 |
| Study Start Date: | September 2004 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: 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 6 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.
PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study within 4-5 years.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed hepatic malignancy
One of the following primary tumor histologies:
Limited unresectable extrahepatic disease on preoperative radiological studies allowed if life-limiting component of progressive disease is in the liver
Limited extrahepatic disease includes, but is not limited to, the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| Principal Investigator: | Marybeth S. Hughes, MD | NCI - Surgery Branch |
More Information
| Study ID Numbers: | CDR0000391827, NCI-04-C-0273, NCI-6332, DELCATH-G990039 |
| Study First Received: | November 9, 2004 |
| Last Updated: | September 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00096083 History of Changes |
| Health Authority: | Unspecified |
|
advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer liver metastases adenocarcinoma of the colon adenocarcinoma of the esophagus adenocarcinoma of the extrahepatic bile duct adenocarcinoma of the gallbladder adenocarcinoma of the pancreas adenocarcinoma of the rectum adenocarcinoma of the stomach carcinoma of the appendix recurrent gallbladder cancer unresectable gallbladder cancer recurrent colon cancer |
stage IV colon cancer recurrent esophageal cancer stage IV esophageal cancer recurrent extrahepatic bile duct cancer unresectable extrahepatic bile duct cancer recurrent gastric cancer stage IV gastric cancer recurrent rectal cancer stage IV rectal cancer small intestine adenocarcinoma recurrent small intestine cancer recurrent islet cell carcinoma recurrent pheochromocytoma metastatic pheochromocytoma pulmonary carcinoid tumor |
|
Melphalan Liver Diseases Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Alkylating Agents |