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

Primary Purpose

Head and Neck Cancer, Islet Cell Tumor, Metastatic Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
octreotide acetate
yttrium Y 90 resin microspheres
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sir-Spheres

Arm Description

Outcomes

Primary Outcome Measures

Tumor response

Secondary Outcome Measures

Toxicity as measured by CTC v3.0
Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary
The Carcinoid Symptom Severity Scale is a self-report instrument that addresses the severity and frequency of symptoms and their impact on daily living.
Patient report of Health-related quality of life (HRQOL)
HRQOL will be determined via the Medical Outcome Study 36-item short form, which includeds 8 individual scales, physical and mental component summary scores and is normed to both health and clinical populations.

Full Information

First Posted
April 25, 2007
Last Updated
May 17, 2012
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00466856
Brief Title
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

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
due to slow accrual
Study Start Date
December 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sir-Spheres
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
octreotide acetate
Other Intervention Name(s)
octreotide
Intervention Description
Lung/liver Ratio Dose of SIR-Spheres <10% Administer full dose of SIR-Spheres 10% to 15% Reduce dose of SIR-Spheres by 20% 16% to 20% Reduce dose of SIR-Spheres by 40% >20% Do not give SIR-Spheres
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 resin microspheres
Other Intervention Name(s)
octreotide
Intervention Description
radiation
Primary Outcome Measure Information:
Title
Tumor response
Time Frame
at 1 year or until intervening death
Secondary Outcome Measure Information:
Title
Toxicity as measured by CTC v3.0
Time Frame
at 1 year or until intervening death
Title
Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary
Description
The Carcinoid Symptom Severity Scale is a self-report instrument that addresses the severity and frequency of symptoms and their impact on daily living.
Time Frame
at 1 year or until intervening death
Title
Patient report of Health-related quality of life (HRQOL)
Description
HRQOL will be determined via the Medical Outcome Study 36-item short form, which includeds 8 individual scales, physical and mental component summary scores and is normed to both health and clinical populations.
Time Frame
at 1 year or until intervening death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven G. Meranze, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

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

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