Clinical trial NCT00466856: Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors
Official title: Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Islet Cell Tumor
Metastatic Cancer
Pheochromocytoma
Keywords: neoplastic syndrome
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
thyroid gland medullary carcinoma
metastatic pheochromocytoma
recurrent islet cell carcinoma
liver metastases
recurrent pheochromocytoma
gastrinoma
insulinoma
WDHA syndrome
glucagonoma
pancreatic polypeptide tumor
somatostatinoma
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-04-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 studying how well internal radiation therapy works in treating patients with liver metastases from neuroendocrine tumors.

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 neuroendocrine tumors.

Secondary

* Determine the toxicity of this treatment in these patients.
* Determine the symptomatic relief of patients treated with this regimen.
* Determine the health-related quality of life of patients receiving this treatment.

OUTLINE: Patients have an catheter placed into the hepatic artery percutaneously through the groin and then undergo selective internal radiation therapy with yttrium Y 90 resin microspheres (Sir-Spheres®) via the catheter on day 1. Patients also receive octreotide acetate IV 1 hour prior to, during, and 2 hours after Sir-Spheres® injection. Patients may undergo above treatment in another lobe of the liver (if each lobe is treated separately) 4 weeks later.

Patients undergo functional performance, health-related quality of life, and symptom severity assessment prior to initial treatment and after completion of study treatment.

After completion of study treatment, patients are followed periodically for at least 1 year.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor response
timeFrame: at 1 year or until intervening death
Secondary outcomes:
measure: Toxicity as measured by CTC v3.0
timeFrame: at 1 year or until intervening death
measure: Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary
timeFrame: at 1 year or until intervening death
measure: Patient report of Health-related quality of life (HRQOL)
timeFrame: at 1 year or until intervening death
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Steven G. Meranze, MD
role: PRINCIPAL_INVESTIGATOR
References: