Head and Neck CancerPhase 2NCT00466856
Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors
A Phase 2 study testing octreotide acetate and yttrium Y 90 resin microspheres in people with Head and Neck Cancer and Islet Cell Tumor, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Islet Cell Tumor, Metastatic Cancer
- What is being tested?
- octreotide acetate and yttrium Y 90 resin microspheres
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Oct 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors
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.
Read the 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.
- Being tested
- octreotide acetate, yttrium Y 90 resin microspheres
- 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
- Medical subject headings
- Head and Neck Neoplasms, Adenoma, Islet Cell, Neoplasm Metastasis, Pheochromocytoma, Neoplasms, Carcinoma, Medullary, Carcinoma, Islet Cell, Gastrinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
octreotide acetateDrug
Also called octreotide
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
yttrium Y 90 resin microspheresRadiation
Also called octreotide
radiation
| Study group | Role | What they receive |
|---|---|---|
| Sir-Spheres | Experimental | Not described Receives: Drug: octreotide acetate; Radiation: yttrium Y 90 resin microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Measured: at 1 year or until intervening death
Secondary outcomes (3)
Toxicity as measured by CTC v3.0
Measured: at 1 year or until intervening death
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.
Measured: at 1 year or until intervening death
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.
Measured: at 1 year or until intervening death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startDec 2003
- Primary completionOct 2006
- Study completionOct 2007
Why it stopped: due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Steven Meranze, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Steven G. Meranze, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466856
- Sponsor's protocol ID
- VICC GI 0365
- Other IDs
- VU-VICC-GI-0365
- Status last verified
- May 2012
- First submitted
- 25 Apr 2007
- Last updated
- 18 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT00466856
- Acronym / sponsor ID
- VICC GI 0365
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to slow accrual
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sir-Spheres | Experimental | Drug: octreotide acetate, Radiation: yttrium Y 90 resin microspheres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| octreotide acetateAlso: octreotideLung/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 | Drug | Sir-Spheres |
| yttrium Y 90 resin microspheresAlso: octreotideradiation | Radiation | Sir-Spheres |
Primary outcome
Tumor response
Time frame: at 1 year or until intervening death
3 secondary outcomes
Toxicity as measured by CTC v3.0
Time frame: at 1 year or until intervening death
Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary
Time frame: at 1 year or until intervening death
Patient report of Health-related quality of life (HRQOL)
Time frame: at 1 year or until intervening death
Results and safety
The study was stopped early (reason given: due to slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven G. Meranze, MD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing octreotide acetate and yttrium Y 90 resin microspheres in people with Head and Neck Cancer and Islet Cell Tumor, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: due to slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response (time frame: at 1 year or until intervening death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2012.