Clinical trial NCT00605150: HDE Use Protocol of TheraSphere for Treatment of Unresectable HCC
Official title: A Humanitarian Device Exemption (HDE) Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Unresectable HCC
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-01-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be selected from the population of patients with unresectable cancer in the liver who are referred by surgeons and medical oncologists of CarolinasHealthCare System and by other referring physicians in the geographic area for regional therapy for liver cancer. Patients to be considered for treatment under this protocol will have been referred to one of the clinicians.

Brief summary: MDS Nordion's TheraSphere, Yttrium-90 glass microspheres has been approved as a Humanitarian device authorized by federal(USA)law for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma(HCC)who can have placement of appropriately positioned hepatic arterial catheters. Outcomes of this treatment protocol will be monitored and reported to the Carolinas HealthCare System Institutional Review Board.

Detailed description: The objectives of this study are to provide supervised access to treatment with TheraSphere to eligible patients with Hepatocellular Carcinoma of the liver who are not surgical resection candidates and to evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.

This is an observational treatment use protocol that will provide Institutional Review Board (IRB) oversight and documentation of the clinical experience of patients undergoing treatment for liver carcinoma using TheraSphere. Participation involves no investigational or research procedures. Patients will be followed for treatment-related adverse experiences and will be monitored in accordance with institutional practices. Approximately 60 patients will be enrolled in a treatment protocol and the number may be expanded following completion of the first cohort. The total number of patients to be treated will be determined based on clinical experience and patient outcomes. There are no control subjects in this treatment protocol.

The duration of the protocol will depend on patient experience with this treatment. An initial one year approval is sought at this time. Patient experience will be evaluated continuously and if the clinicians find that the treatment provides benefits to patients, renewal of the approval will be sought after the first 12 months.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of intrahepatic carcinoma. 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 feta protein (AFP) markers (clinical diagnosis).
* The cancer must be unresectable.
* Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0-2
* Age greater than or equal to 18
* Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

* Any pre-treatment lab findings within 15 days of treatment demonstrating: absolute granulocyte count less than or equal to 1,500/ul, platelet count less than or equal to 45,000/ul, serum creatinine greater than or equal to 3.0 mg/dl, serum bilirubin greater than or equal to 4.0 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
* Portal hypertension with portal venous shunt away from the liver
* Evidence of potential delivery of greater than 16.5 milliCurie (mCi) or 30 gray (Gy) absorbed dose of radiation to the lungs on either 1) first TheraSphere administration or 2) cumulative delivery of radiation to the lungs \> 30 Gy over multiple treatments.
* Evidence of any detectable Tc-99m microaggregate albumin (MAA) flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
* Significant extrahepatic disease representing an imminent life-threatening outcome
* Severe liver dysfunction or pulmonary insufficiency
* Active uncontrolled infection
* Significant underlying medical or psychiatric illness.
* Pregnant women may not participate.

Primary outcomes:
measure: Progression
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Unacceptable Side Effects After Treatment
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Carolinas Medical Center
name: David A Iannitti, MD
role: PRINCIPAL_INVESTIGATOR
References: