Doxorubicin Beads in Treating Patients With Unresectable Liver Metastases From Neuroendocrine Tumors
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Infusing doxorubicin beads into the liver, and blocking blood flow to the tumor, may keep doxorubicin near the tumor and kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects of doxorubicin beads and to see how well they work in treating patients with unresectable liver metastases from neuroendocrine tumors.
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Drug: PVA microporous hydrospheres/doxorubicin hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Patients With Hepatic Neuroendocrine Metastases Using Drug-Eluting Bead Embolization|
- Tumor response (efficacy) [ Time Frame: Time to progression ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 30 days post study exit ] [ Designated as safety issue: Yes ]
- Survival [ Time Frame: overall survival ] [ Designated as safety issue: No ]
- Biochemical response [ Time Frame: Time to progression ] [ Designated as safety issue: No ]
- Symptomatic response [ Time Frame: Time to progression ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: single arm||Drug: PVA microporous hydrospheres/doxorubicin hydrochloride|
- To gather preliminary data and determine the feasibility of a randomized study of patients with unresectable hepatic neuroendocrine metastases using PVA microporous hydrospheres/doxorubicin hydrochloride.
OUTLINE: A catheter is placed into the right or left hepatic artery. Patients with unifocal tumors will have the catheter or microcatheter placed more selectively into the 2nd or 3rd order branch off the right or left hepatic artery in closer proximity to the tumor. PVA microporous hydrospheres/doxorubicin hydrochloride mixture is injected into the delivery area.
Patients with less than 75% necrosis at 1 month undergo a second (and possibly a third a month later) chemoembolization.
After completion of study therapy, patients are followed at 1 month, every 2 months for 1 year, and then every 3 months for 1 year.
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21231-2410|
|Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 firstname.lastname@example.org|
|Principal Investigator:||Jeffrey F. Geschwind, MD||Sidney Kimmel Comprehensive Cancer Center|