Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Nicholas Fidelman

Description

Summary

The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary hypothesis is that chemoembolization will be nearly twice as durable as bland embolization; thatis, the hazard ratio for HPFS will be 1.76 or better.

Keywords

Adults With Unresectable Liver-dominant Neuroendocrine Tumor Metastases That Are Are Symptomatic, Progressive, or Involve 25% of the Liver Volume Neoplasm Metastasis Neuroendocrine Tumors Neoplasms, Second Primary Doxorubicin Liposomal doxorubicin Ethiodized Oil Lobar or segmental bland embolization with microspheres (50-500 microns) to 2-5 heartbeat stasis Lobar or segmental lipiodol transarterial chemoembolization Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres. Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants 18 years and older;
  • Biopsy-proven neuroendocrine tumor.
  • Measurable metastasis to liver with at least one dimension ≥ 1.0 cm.
  • Tumor burden dominant in the liver AND liver tumor burden less than or equal to 70% of the total liver volume by visual estimate.
  • Not a candidate for surgical resection based on unresectability, anatomy, anesthesia risk, patient preference.
  • Symptoms uncontrolled by somatostatin analogues OR morphologically progressive tumor by RECIST 1.1 criteria in the liver OR baseline tumor burden >25% of the liver volume.
  • There must be no plans for the patient to receive other concomitant therapy while on this protocol treatment (other than somatostatin analogs or bone-strengthening agents).
  • Performance status 0-2 on Zubrod/ECOG Performance Scale;
  • Serum creatinine < 2.0 mg/dL;
  • Serum Bilirubin ≤ 2.0 mg/dL
  • Serum albumin ≥ 3.0 g/dL
  • Platelet count > 50 thousands/uL (corrected if needed)
  • INR ≤ 1.5 (corrected if needed)
  • All patients must be informed of the investigational nature of this study and must sign a study specific informed consent in accordance with institutional and federal guidelines prior to study entry.

You CAN'T join if...

  • Pregnant or lactating women may not participate due to the embryotoxic effects of protocol treatment. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • Prior hepatic arterial therapy or hepatic radiation therapy. Prior surgical resection or ablation of liver metastases is acceptable. Patients must be at least one month beyond prior chemotherapy, PRRT, ablation or surgery, and have recovered from all therapy-associated toxicities.
  • Active infection (Symptomatic bacterial and fungal infection - newly diagnosed and/or requiring treatment);
  • Choledochoenteric anastomosis; transpapillary biliary stent, or sphincterotomy of duodenal papilla
  • Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).
  • Contraindications to arteriography and selective visceral catheterization:
  • severe allergy or intolerance to contrast media, narcotics, sedatives, or atropine.
  • bleeding diathesis not correctable by usual forms of therapy.
  • severe peripheral vascular disease precluding catheterization.
  • Contraindications to hepatic artery embolization:
  • portal vein occlusion without hepatopedal collateral flow demonstrated by angiography; or portal hypertension with hepatofugal flow.
  • hepatic encephalopathy.

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Lead Scientist

  • Nicholas Fidelman
    Nicholas Fidelman, MD, is an Associate Professor of Clinical Radiology at the University of California, San Francisco and UCSF Mount Zion. Dr. Fidelman received his medical degree from UCSF in 2002, and completed his residency in Diagnostic Radiology from UCSF in 2007, followed by a fellowship in Interventional Radiology from UCSF in 2008.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Pennsylvania
ID
NCT02724540
Phase
Phase 2
Study Type
Interventional
Last Updated