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Home > "H" Clinical Trials Conditions > Hepatic Arterial Infusion Plus Internal Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery  Hepatic Arterial Infusion Plus Internal Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Hepatic Arterial Infusion Plus Internal Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
For Condition: recurrent adult primary liver cancer,localized unresectable adult primary liver cancer,adult primary hepatocellular carcinoma
Status: Recruiting
Sponsor(s): University of Pittsburgh Cancer Institute ,
Synopsis: RATIONALE: Hepatic arterial infusion uses a catheter to deliver anticancer substances directly into the liver. Internal radiation uses radioactive material placed directly into the tumor to kill tumor cells and cause less damage to normal tissue. PURPOSE: Phase II trial to study the effectiveness of combining hepatic arterial infusion with internal radiation therapy in treating patients who have liver cancer that can not be removed by surgery.
Details: OBJECTIVES: - Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium Y 90 glass microspheres (TheraSphere). - Determine the toxic effects and adverse experiences associated with this therapy in these patients. - Determine the survival time of patients treated with this therapy. - Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy. - Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy. - Assess the quality of life of patients treated with this therapy. OUTLINE: Patients receive yttrium Y 90 glass microspheres (TheraSphere) via hepatic arterial infusion using the TheraSphere administration set on day 1. Courses repeat every 2-4 months (until all tumor in the liver has been treated) in the absence of disease progression, unacceptable toxicity, or a cumulative lung dose of more than 30 Gy. Quality of life is assessed at baseline, monthly for 3 months, and then every 3 months for 9 months. Patients are followed monthly for 3 months, every 3 months for 9 months, and then every 4 months for 1 year. PROJECTED ACCRUAL: A maximum of 15 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed unresectable primary hepatocellular carcinoma (HCC) - Histopathologic confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for HCC, and an alpha-fetoprotein level greater than 1,000 ng/mL - Known extrahepatic disease limited to lymph nodes of less than 2 cm - Measurable or evaluable disease by CT scan or MRI PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 60,000/mm^3 - No bleeding diathesis not correctable by usual forms of therapy Hepatic: - See Disease Characteristics - Bilirubin no greater than 3.0 mg/dL - No portal vein thrombosis - No portal hypertension with hepatofugal flow - No severe liver dysfunction Renal: - Creatinine no greater than 2.0 mg/dL - No renal insufficiency Cardiovascular: - No vascular abnormalities or severe peripheral vascular disease that would preclude angiography or selective visceral catheterization Pulmonary: - No pulmonary insufficiency Other: - No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiotherapy to the lungs on either the first yttrium Y 90 glass microspheres (TheraSphere) administration or with cumulative delivery of radiation to the lungs over multiple treatments - No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the stomach or duodenum after application of established angiographic techniques to stop such flow - No contraindications to angiography - No contraindications to selective visceral catheterization - No allergy to contrast dye - No other prior or concurrent malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No other condition that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 30 days after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No more than 1 prior immunotherapy treatment for HCC Chemotherapy: - At least 1 month since prior chemotherapy - No more than 1 prior chemoembolization treatment for HCC - No more than 1 prior systemic chemotherapy regimen for HCC Endocrine therapy: - Not specified Radiotherapy: - No prior external hepatic radiotherapy for HCC Surgery: - See Disease Characteristics - At least 1 month since prior surgery Other: - No prior intra-arterial treatment for HCC - No other concurrent investigational agents or anticancer therapy for HCC
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrianCarr, Study Chair, University of Pittsburgh Cancer Institute
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15236
United States
Recruiting Brian Carr 412-623-4000
Additional Information:
Study ID Numbers: CDR0000069336; NCI-V02-1701,PCI-IRB-000871,PCI-IRB-000656
Study Start Date:
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039078
Other Localized Unresectable Adult Primary Liver Cancer Studies:
1. DX-8951f in Treating Patients With Liver Cancer
2. Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer
3. Vaccine Therapy in Treating Patients With Liver Cancer
4. Epirubicin and Thalidomide in Treating Patients With Liver Cancer
5. T900607 in Treating Patients With Unresectable Liver Cancer
Related Studies:
Other localized unresectable adult primary liver cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Hepatic Arterial Infusion Plus Internal Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
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