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Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier:
NCT00701168
First received: June 17, 2008
Last updated: October 4, 2010
Last verified: October 2010
  Purpose

The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.


Condition Intervention
Carcinoma, Hepatocellular
Neoplasm Metastasis
Device: yttrium Y 90 microspheres (Therasphere®)

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Humanitarian Device Exemption Use Protocol of Therasphere® for Treatment of Unresectable Hepatocellular and Metastatic Liver Tumors - HDE #980006

Resource links provided by NLM:


Further study details as provided by Leo W. Jenkins Cancer Center:

Intervention Details:
    Device: yttrium Y 90 microspheres (Therasphere®)
    This is a local therapy for unresectable liver tumors with limited treatment options. It may be repeated under special circumstances.
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of primary or metastatic intrahepatic carcinoma
  • The cancer must be unresectable with limited established treatment options
  • ECOG Performance Status Score 0-2
  • Age 19 years or older
  • Able to comprehend and provide written informed consent

Exclusion Criteria:

  • Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
  • Absolute granulocyte count ≤ 1,500/ul
  • Platelet count ≤ 75,000/ul
  • Serum creatinine > 2.0 mg/dl
  • Serum bilirubin ≥ 2.0 mg/dl
  • Any of the following contraindications to angiography and selective visceral catheterization:
  • History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
  • Bleeding, diathesis, not correctable by usual forms of therapy
  • Severe peripheral vascular disease that would preclude catheterization
  • Substantial venous shunt away from the liver
  • Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments
  • Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow
  • Significant extrahepatic disease representing an imminent life- threatening situation outcome
  • Severe liver dysfunction or pulmonary insufficiency
  • Active uncontrolled infection
  • Significant underlying medical or psychiatric illness
  • Pregnant women may not participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701168

Locations
United States, North Carolina
Leo W Jenkins Cancer Center at East Carolina University School of Medicine
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Leo W. Jenkins Cancer Center
Investigators
Principal Investigator: Suzanne Russo, MD East Carolina University School of Medicine
  More Information

Publications:
Russell JL Jr, Carden JL, Herron HL. Dosimetry calculations for yttrium-90 used in the treatment of liver cancer. Endocurietherapy/Hyperthermia Oncology. 1988; 4:171-186.
Boos G, Thirwell M, Blanchard R, et al. Phase I-II study of hepatic arterial infusion of yttrium-90 (Y-90) glass microspheres in cancer of the liver. Proc Am Soc Clin Oncol. 1989, 8:103.
Patt YZ, Charnsangavej C, Boddie A, et al. Treatment of hepatocellular carcinoma with hepatic arterial floxuridine, doxorubicin, and mitomycin C (FUDRM) with or without hepatic arterial embolization: factors associated with longer arterial survival. Reg Cancer Treat. 1989; 2:98.
Douglass C. Prolongation of survival with periodic percutaneous multi-drug arterial infusions in patients with primary and metastatic gastrointestinal carcinoma to liver, abstracted. Proc Am Soc Clin Oncol. 1980; 21:416
Stuart K. Invited commentary on preoperative lipiodol for unresectable HCC. World J Surg 1996; 20:331
Harbert JC, Ziessman HA. Therapy with intra-arterial microspheres. Nuclear Medicine Annual 1987, edited by Freeman L.M., Weissman H.S. Raven Press, New York.
Prinzmetal MB, Simkin B, Bergman HC, Kruger, HE. Studies on coronary circulation. American Heart Jornal. 1947; 33:420.
Pinzmetal MB, Ornitz EM, Simkin B. Arteriovenous anastomoses in liver, spleen, and lungs. American Journal of Physiology. 1948; 152:48.
Gross P. The effects of fibrous glass dust on the lungs of animals. In: Occupational exposure to fibrous glass of a symposium presented to the Center of Adult Education; 1976; University of Maryland, College Park, MD. 169-178.

Responsible Party: Suzanne Russo, MD, Principal Investigator, East Carolina University School of Medicine
ClinicalTrials.gov Identifier: NCT00701168     History of Changes
Other Study ID Numbers: LJCC 07-04
Study First Received: June 17, 2008
Last Updated: October 4, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasm Metastasis
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014