Clinical trial NCT02072356: Radiolabeled Glass Beads in Treating Patients With Liver Cancer That Cannot be Removed by Surgery
Official title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Keywords: Humanitarian Device
Carcinoma
Hepatocellular Carcinoma
TheraSphere®
HUD
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 290
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial studies radiolabeled glass beads (yttrium Y 90 glass microspheres) in treating patients with unresectable hepatocellular carcinoma. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be an effective treatment for liver cancer.

Detailed description: PRIMARY OBJECTIVES:

I. Provide oversight to treatment with TheraSphere to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.

II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.

OUTLINE:

Patients receive yttrium Y 90 glass microspheres intra-arterially (IA) on day 0, and may receive a second dose within 30-90 days of initial treatment. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician.

After completion of study treatment, patients are followed up at 3-6 weeks and annually for 2 years.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of intrahepatic malignancy including but not limited to 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 alpha-fetoprotein (AFP) and clinical findings
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
* Life expectancy \>= 3 months
* \> 4 weeks since prior radiation, surgery or chemotherapy
* Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
* Ineligible for surgical resection

Exclusion Criteria:

* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times upper limit of normal (UNL)
* Serum bilirubin \> 2.0 mg/dl (unless segmental infusion is planned)
* 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
* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs in a single treatment
* Evidence of pulmonary insufficiency
* Evidence of any detectable technetium-99m macroaggregated serum albumin (Tc-99m MAA) flow to the stomach or duodenum, not correctable by using established angiographic techniques to stop or mitigate such flow
* Significant extrahepatic disease representing an imminent life-threatening outcome
* Active uncontrolled infection
* Significant underlying medical or psychiatric illness
* 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
* Pregnancy

Primary outcomes:
measure: Response to treatment
timeFrame: Up to 2 years
measure: Survival time
timeFrame: Up to 2 years
measure: Adverse experiences
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Rikabi Ali, M.D.
role: PRINCIPAL_INVESTIGATOR
References: