Trial record 11 of 12 for:    Open Studies | "Carcinoma, Islet Cell"

Doxorubicin Beads in Treating Patients With Unresectable Liver Metastases From Neuroendocrine Tumors

This study is currently recruiting participants.
Verified January 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00730483
First received: August 7, 2008
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Metastatic Cancer
Drug: PVA microporous hydrospheres/doxorubicin hydrochloride

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
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)
Arms Assigned Interventions
Experimental: single arm Drug: PVA microporous hydrospheres/doxorubicin hydrochloride

Detailed Description:

OBJECTIVES:

Primary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Diagnosis of hepatic neuroendocrine metastases not suitable for radical therapies (e.g., resection or liver transplantation)

    • Histologically proven neuroendocrine tumor
    • Tumors are hypervascular based on visual estimation by investigator
  • Predominant to the liver disease, but extrahepatic disease is not an exclusion

    • No predominant extrahepatic liver disease
    • No significant life-threatening extrahepatic disease, in the judgment of the physician
  • Recent-interval progression of hepatic liver metastases
  • No diffuse hepatic neuroendocrine metastases defined as massive ill-defined tumor involvement measuring > 90% tumor burden

Exclusion criteria:

  • Clinically evident ascites (a radiographic finding of trace ascites on imaging is acceptable)
  • Complete occlusion of the entire portal venous system
  • Evidence of cirrhosis or portal hypertension
  • Vascular resistance peripheral to the feeding arteries precluding passage of PVA microporous hydrospheres/doxorubicin hydrochloride

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-2
  • Must have preserved liver function (Child-Pugh class A-B) without significant liver decompensation

    • No advanced liver disease (e.g., Child-Pugh C class or active gastrointestinal bleeding, encephalopathy, or ascites [trace ascites is acceptable]), meeting the following criteria:

      • Bilirubin > 3 mg/dL
      • AST, ALT, and alkaline phosphatase > 5 times upper limit of normal
      • Serum creatinine > 2.0 mg/dL
      • Albumin ≤ 2.0 g/dL
  • No vascular anatomy or blood that precludes catheter placement or emboli injection
  • No presence of arteries supplying the lesion not large enough to accept PVA microporous hydrospheres/doxorubicin hydrochloride
  • No collateral vessel pathways potentially endangering normal territories during embolization
  • No feeding arteries smaller than distal branches from which they emerge
  • Not pregnant

Exclusion criteria:

  • See Disease Characteristics
  • Another active primary tumor
  • Any contraindication for hepatic embolization procedures, including any of the following:

    • Porto-systemic shunt
    • Hepatofugal blood flow
    • Impaired clotting tests (i.e., platelet count < 50,000/mm³, INR ≥ 1.8, or PTT ≥ 39 seconds)
    • Renal failure
    • Severe peripheral vascular disease precluding catheterization
  • Any contraindication for doxorubicin hydrochloride administration (i.e., serum bilirubin > 5 mg/dL or leukocyte count < 1,500 cells/mm³)
  • Allergy to contrast media
  • Intolerant to occlusion procedures
  • Presence of end arteries leading directly to cranial nerves
  • Presence or likely onset of hemorrhage
  • Presence of severe atheromatous disease

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

  • Prior anticancer therapy for hepatic neuroendocrine metastases, except previous surgical therapy
  • Any continuing complication or prior cancer therapy that has not improved or resolved prior to 21 days before start of treatment, if the investigator determines that the continuing complication will compromise the safety of the patient after treatment with PVA microporous hydrospheres/doxorubicin hydrochloride
  • Presence of patent extra-to-intracranial anastomoses or shunts
  • Use of PVA microporous hydrospheres/doxorubicin hydrochloride in the following applications:

    • Embolization of large-diameter arteriovenous shunts
    • Pulmonary arterial vasculature
    • Any vasculature where the use of PVA microporous hydrospheres/doxorubicin hydrochloride could pass directly into the internal carotid artery or the above-listed vessels
  • Concurrent enrollment in another clinical study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730483

Locations
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    jhcccro@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Jeffrey F. Geschwind, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided by Sidney Kimmel Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00730483     History of Changes
Other Study ID Numbers: J0739 CDR0000601054, JHOC-J7039, JHOC-NA_000010736, JHOC-SKCCC-J7039
Study First Received: August 7, 2008
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
liver metastases
metastatic gastrointestinal carcinoid tumor
regional gastrointestinal carcinoid tumor
islet cell carcinoma
gastrinoma
insulinoma
glucagonoma
pancreatic polypeptide tumor
somatostatinoma

Additional relevant MeSH terms:
Carcinoid Tumor
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neuroendocrine Tumors
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Adenoma
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014