Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors

Vanderbilt University Medical Center

Status and phase

Terminated

Phase 2

Conditions

Metastatic Cancer

Islet Cell Tumor

Head and Neck Cancer

Pheochromocytoma

Treatments

Radiation: yttrium Y 90 resin microspheres

Drug: octreotide acetate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00466856

VICC GI 0365

VU-VICC-GI-0365

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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