Humanitarian Device Exemption (HDE) Treatment Protocol

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
BTG International Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01176604
First received: August 4, 2010
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

Objectives:

There are no hypotheses to be tested in this treatment protocol which has the following objectives:

  • Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.
  • Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.

Condition Intervention
Carcinoma, Hepatocellular
Liver Cancer
Device: TheraSphere Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Protocol For Use of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall Survival Associated With TheraSphere Treatment [ Time Frame: 3-6 weeks post treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: August 2010
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TheraSphere Treatment
Injection via arterial catheter of TheraSphere microspheres containing yttrium-90 (Y-90) to whole liver, lobar or segmental treatment delivered as a sequence of treatments using approximately 30 - 90 days apart.
Device: TheraSphere Treatment
Injection via arterial catheter of TheraSphere microspheres containing yttrium-90 (Y-90) to whole liver, lobar or segmental treatment delivered as a sequence of treatments using approximately 30 - 90 days apart.

Detailed Description:

TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used to treat liver tumors. When Y-90 is put into microscopic glass beads, called microspheres, it can be injected directly into the liver by vein. This allows a large dose of radiation to be delivered directly to the tumor, which lowers the risk of experiencing toxic radiation side effects from the radiation to in other parts of the body, or to healthy liver tissue. The radiation from TheraSphere treatment stays in the body and begins to lose its effect within 12 days, due to physical decay (please refer to the package insert for more information for more information regarding this). The glass microspheres will stay in the body from that point on, but should not cause any health problems.

All visits and procedures related to the TheraSphere treatment will be performed on an outpatient basis. About 2 weeks before the treatment begins, a small tube (catheter) will be inserted into a vein that goes to the liver, usually in the thigh.

TheraSphere Treatment:

TheraSphere (microspheres filled with Y-90 as described above) will be injected into the tumor in the liver through a catheter that you have already had placed into an artery during an earlier procedure.

You will receive at least 1 TheraSphere injection while you are receiving the treatment. If the doctor thinks it is needed, you will have a second injection about 1 month later. The number of TheraSphere injections you will receive will depend on the size and location of the tumors. The injection should take about 5 minutes to complete each time.

After receiving the TheraSphere injection, you will stay at the hospital for several hours so that the staff can check you for possible side effects. If you experience any serious problems or complications after receiving the injection, you may be admitted to the hospital for observation and possible additional treatment.

Length of Treatment:

You will continue to receive the HUD treatment indefinitely.

TheraSphere is a humanitarian use device that is approved by the FDA for the treatment of rare disorders affecting less than 4,000 people in the U.S. each year.

All of the tests and procedures that will be performed as part of this treatment protocol are considered to be standard care, including the TheraSphere.

Up to 200 patients will receive the treatment. All will be enrolled at M.D. Anderson.

  Eligibility

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

Inclusion Criteria:

  1. Diagnosis of unresectable intrahepatic HCC. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alphafetoprotein (AFP)^21 and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing HCC.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 1
  3. Life expectancy >/= 3 months
  4. > 4 weeks since prior radiation, surgery or chemotherapy
  5. Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

  1. Any pre-treatment laboratory findings within 15 days of treatment demonstrating liver dysfunction: • AST (Serum Glutamic-Oxalacetic Transaminase - SGOT) or ALT (Serum Glutamic-Pyruvic Transaminase - SGPT) > 5 times Upper Normal Limit (UNL) • Serum bilirubin > 2.0 mg/dl (unless segmental infusion is planned)
  2. Any contraindications to angiography and hepatic artery catheterization such as: History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated; Bleeding diathesis, not correctable by usual forms of therapy; Severe peripheral vascular disease that would preclude catheterization.
  3. Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
  4. Clinical evidence of pulmonary insufficiency
  5. Evidence of any detectable Technetium-99 Macroaggregated Albumin (Tc-99m MAA) flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow.
  6. Complete occlusion of the main portal vein.
  7. Significant extrahepatic disease representing an imminent life-threatening outcome
  8. Active uncontrolled infection.
  9. Significant underlying medical or psychiatric illness.
  10. Co-morbid disease of condition that would preclude safe delivery of TheraSphere treatment or, in the judgment of the physician, place the patient at undue risk
  11. Pregnancy
  12. Tumor type demonstrated on imaging to be infiltrative, tumor volume > 70% of the target liver volume, or tumor nodules too numerous to count, or tumor volume > 50% combined with an albumin < 3 g/dL, or complete occlusion of the main portal vein.
  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: NCT01176604

Contacts
Contact: Armeen Mahvash, MD 713-563-7340

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
BTG International Inc.
Investigators
Principal Investigator: Armeen Mahvash, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01176604     History of Changes
Other Study ID Numbers: 2008-0770, NCI-2010-01956
Study First Received: August 4, 2010
Last Updated: April 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Hepatocellular carcinoma (HCC) of the liver
Hepatocellular cancer
Hepatocellular carcinoma
Liver cancer
HCC
Humanitarian Device Exemption
Liver Diseases
(HDE)
Radioactive
TheraSphere

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

ClinicalTrials.gov processed this record on October 01, 2014