Status:
TERMINATED
Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Islet Cell Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is...
Detailed Description
OBJECTIVES: Primary * Determine tumor response to selective internal radiation therapy with yttrium Y 90 resin microspheres (Sir-Spheres®) in patients with progressive liver metastases from neuroend...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Pathologically confirmed neuroendocrine tumor metastatic to the liver
- Well-differentiated or moderately well-differentiated neuroendocrine tumors
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral CT scan
- Symptomatic disease, meeting one of the following criteria:
- Refractory carcinoid symptoms, defined as Carcinoid Symptom Severity scale \> 2 despite use of octreotide acetate at ≥ 200 mcg subcutaneously three times daily (or 20 mg intramuscularly once monthly) for ≥ 4 weeks
- Evidence of radiographic progression with either of the following manifestations:
- Moderate-severe right upper quadrant pain and unintentional weight loss \> 10%
- Decline in Karnofsky performance status \> 10 points
- At least a 20% increase in the sum of the longest diameters of target lesions in the liver within the past 12 months
- No more than 75% replacement of normal liver by neuroendocrine tumor
- No more than 20% arteriovenous lung shunting on a technetium Tc 99m macro-aggregated albumin nuclear scan
- No equivocal, nonmeasurable, or nonevaluable liver metastasis
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 50-100%
- Life expectancy ≥ 6 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Creatinine ≤ 1.5 mg/dL
- Bilirubin ≤ 2.0 mg/dL
- Albumin ≥ 3.0 g/dL
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 65,000/mm³
- Hemoglobin \> 9.0 g/dL
- INR ≤ 1.4
- No hepatic arterial anatomy that would preclude the administration of study treatment into the liver
- No nonmalignant disease that would preclude study participation
- No other malignancy within the past 5 years except for cured basal cell carcinoma of the skin or cured carcinoma in situ of the uterine cervix
- PRIOR CONCURRENT THERAPY:
- Prior surgery, chemotherapy, or locally ablative technique for the liver cancer allowed
- No prior radiotherapy to the upper abdomen that includes the liver in the treatment field
- No investigational drug or agent/procedure (i.e., participation in another clinical trial) within the past 4 weeks
- No other specific anticancer treatment (other than octreotide acetate) during and for 3 months after completion of study therapy
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00466856
Start Date
December 1 2003
End Date
October 1 2007
Last Update
May 18 2012
Active Locations (1)
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1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838