Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hematinics

All Drugs and Chemicals

Liver Extracts

Technetium Tc 99m Aggregated Albumin

Radiopharmaceuticals

The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging.

All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours.

Angiography

Computed Tomography

Planar Imaging

Radioembolization

Single Photon Emission Computed Tomography

Technetium Tc-99m Albumin Aggregated

Yttrium Y 90 Resin Microspheres

Armeen Mahvash

This clinical trial studies the side effects and best way to perform yttrium Y-90 radioembolization in treating patients with liver cancer that has spread to other places in the body (metastatic). Yttrium Y-90 radioembolization is a therapy that injects radioactive microspheres directly into an artery that feeds liver tumors to cut off their blood supply. Performing yttrium Y-90 radioembolization in a single session may make treatment faster, minimize patient travel, and decrease the overall cost of the procedure.

PRIMARY OBJECTIVE:

I. To evaluate the feasibility and safety of same day yttrium-90 radioembolization planning and treatment angiography.

SECONDARY OBJECTIVES:

I. To determine the patient costs associated with same diagnostic and treatment compared when compared to the standard two session methodology.

II. To determine the time required to perform the mandatory in-room technetium Tc-99m albumin aggregated (99mTc-MAA) imaging and the associated calculations for the lung shunt fraction and treatment 90Y-microsphere activity.

III. To determine the time for delivery of the therapy 90Y-microsphere radioactivity to the angiography suite after the therapy written directive by the authorized user.

OUTLINE:

The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging.

All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours.

After completion of study treatment, patients are followed up at 1, 3, and 6 months.

Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer

Feasibility of Single Session In-Room Yttrium-90 Radioembolization Diagnostic Angiography and Treatment

Success will be defined as treatment dose calculated and patient treated on the same day of initial radiation. Feasibility will be defined as at least 9 successful same day treatments. A procedure lasting greater than 4 hours will be considered a failure. The time associated with various aspects of the same-day yttrium Y-90 radioembolization procedure will be determined. Will determine the time and cost for the patient and for MD Anderson Cancer Center between the same day yttrium Y-90-radioembolization treatment and the current standard of care two-day treatment schedule. Success status will be summarized using frequencies and percentages. Success rate will be estimated along with exact 95% confidence interval. Patient characteristics will be summarized using appropriate summary statistics.

The summaries will be overall (severity grades 1 through 5). Actions taken for grade 3 events will also be reported. The summaries will present the number and percentage of patients reporting and adverse event for each classification level as well as the number events reported. Laboratory values will be summarized by the treatment group over time.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Neoplasm Metastasis

Pancreatic Neoplasms

Recurrence

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

Fluorouracil

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

fluorouracil

selective external radiation therapy

tomotherapy

yttrium Y 90 glass microspheres

yttrium Y 90 resin microspheres

Kenneth L. Pennington, MD

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. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy in different ways and giving it together with chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving internal radiation therapy and external radiation therapy together with fluorouracil works in treating patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot be removed by surgery.

OBJECTIVES:

Primary

* Determine tumor response in patients with unresectable, newly diagnosed or recurrent pancreatic cancer and liver metastases treated with selective internal radiotherapy with yttrium Y 90 microspheres, selective external radiotherapy with tomotherapy, and fluoroucacil.
* Determine hepatic and systemic toxicity of this regimen in these patients.

Secondary

* Determine the efficacy of this regimen, in terms of time to progression and survival, in these patients.

OUTLINE: Patients receive fluorouracil IV continuously on days 1-4. Patients undergo selective internal radiotherapy with yttrium Y 90 microspheres on day 2 and selective external radiotherapy with tomotherapy on day 3.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Internal Radiation Therapy With Y-90 Microspheres, External Radiation Therapy With Tomotherapy, and Fluorouracil in Treating Patients With Newly Diagnosed or Recurrent Pancreatic Cancer and Liver Metastases That Cannot Be Removed By Surgery

Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer

Goshen Health System

Kenneth Lee Pennington

Syndrome

Pheochromocytoma

Thyroid Diseases

Head and Neck Neoplasms

Neuroendocrine Tumors

Carcinoid Tumor

Carcinoma, Medullary

Carcinoma, Islet Cell

Insulinoma

Gastrinoma

Glucagonoma

Zollinger-Ellison Syndrome

Somatostatinoma

Adenoma

Adenoma, Islet Cell

Neoplastic Processes

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Paraganglioma

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Thyroid Cancer, Medullary

WDHA Syndrome

Neuroepithelioma

Paragangliomas 1

Gastrointestinal Agents

Octreotide

Pancreatic Polypeptide

Antineoplastic Agents, Hormonal

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

octreotide acetate

Steven G. Meranze, MD

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.

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.

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

Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors

The Carcinoid Symptom Severity Scale is a self-report instrument that addresses the severity and frequency of symptoms and their impact on daily living.

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.

Vanderbilt-Ingram Cancer Center

Vice-Chair, Department of Radiology and Radiological Science; Professor of Radiology and Surgery; Interventional Radiologist

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer	NCT03028311	Metastatic Live... Stage IV Liver ... Stage IVA Liver... Stage IVB Liver...	Angiography Computed Tomogr... Planar Imaging Radioembolizati... Single Photon E... Technetium Tc-9... Yttrium Y 90 Re...	18 Years -	M.D. Anderson Cancer Center
Internal Radiation Therapy With Y-90 Microspheres, External Radiation Therapy With Tomotherapy, and Fluorouracil in Treating Patients With Newly Diagnosed or Recurrent Pancreatic Cancer and Liver Metastases That Cannot Be Removed By Surgery	NCT00436267	Metastatic Canc... Pancreatic Canc...	fluorouracil selective exter... tomotherapy yttrium Y 90 gl... yttrium Y 90 re...	18 Years -	National Cancer Institute (NCI)
Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors	NCT00466856	Head and Neck C... Islet Cell Tumo... Metastatic Canc... Pheochromocytom...	octreotide acet... yttrium Y 90 re...	18 Years -	Vanderbilt-Ingram Cancer Center
Internal Radiation Therapy With Y-90 Microspheres, External Radiation Therapy With Tomotherapy, and Fluorouracil in Treating Patients With Newly Diagnosed or Recurrent Pancreatic Cancer and Liver Metastases That Cannot Be Removed By Surgery	NCT00436267	Metastatic Canc... Pancreatic Canc...	fluorouracil selective exter... tomotherapy yttrium Y 90 gl... yttrium Y 90 re...	18 Years -	National Cancer Institute (NCI)
Internal Radiation Therapy With Y-90 Microspheres, External Radiation Therapy With Tomotherapy, and Fluorouracil in Treating Patients With Newly Diagnosed or Recurrent Pancreatic Cancer and Liver Metastases That Cannot Be Removed By Surgery	NCT00436267	Metastatic Canc... Pancreatic Canc...	fluorouracil selective exter... tomotherapy yttrium Y 90 gl... yttrium Y 90 re...	18 Years -	National Cancer Institute (NCI)
Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer	NCT03028311	Metastatic Live... Stage IV Liver ... Stage IVA Liver... Stage IVB Liver...	Angiography Computed Tomogr... Planar Imaging Radioembolizati... Single Photon E... Technetium Tc-9... Yttrium Y 90 Re...	18 Years -	M.D. Anderson Cancer Center

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