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

Vanderbilt University Medical Center logo

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Sir-Spheres
Experimental group
Treatment:
Drug: octreotide acetate
Radiation: yttrium Y 90 resin microspheres

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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