Intra-arterial Y-90 TheraSpheres for Hepatic Metastases From Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01177007
First received: August 2, 2010
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

This study is an open label prospective trial of TheraSphere treatment for patients who have liver metastases who have failed or are intolerant to other systemic or liver directed therapies. Patients will be treated with TheraSphere at doses of 120 ± 10% Gy, and then followed for time to progression (TTP), safety, and overall survival.


Condition Intervention Phase
Liver Neoplasms
Device: TheraSphere, Yttrium-90 glass Microspheres
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-arterial Y-90 TheraSpheres for Hepatic Metastases From Solid Tumors

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Time to progression (TTP) of the treated lesion(s) according to RECIST criteria [ Time Frame: Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression (TTP) of the treated lesion(s) according to EASL criteria [ Time Frame: Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter. ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: open-ended ] [ Designated as safety issue: No ]
    Measured from the date corresponding to initiation of therapy until the date of death due to any cause.

  • Safety as graded by CTCAE version 3.0 [ Time Frame: Evaluated at 2 and 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TheraSphere Device: TheraSphere, Yttrium-90 glass Microspheres
Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each treated lobe.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 18 years of age or older,
  • Patients with a diagnosis of metastatic disease to the liver who have failed or are intolerant to other systemic or liver directed therapies.

A patient is considered to have failed to other systemic or liver-directed therapies when, in the opinion of the referring physician, the patient has progression of disease after receiving standard approved therapies. Specifically, if a patient has failed first line chemotherapy (or the standard approved therapies for that particular solid tumor), in the time period designed to assess that particular regimen (at least 30 days), then they may be enrolled into this protocol.

A patient is intolerant to other systemic or liver-directed therapies when, in the opinion of the referring physician, for example, the patient is unable to tolerate appropriate chemotherapy, when the patient had residual toxicity from previous therapies (e.g. neuropathy from oxaliplatin), or when the patient's performance status is such that treatment with systemic therapies would result in excessive toxicity.

  • Liver metastases are unresectable
  • Target tumors should be measurable using standard imaging techniques
  • Tumor replacement ≤ 70% of total liver volume based on visual estimation by the Investigator
  • Tumors are hypervascular based on visual estimation by the Investigator
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2
  • At least one month has elapsed since most recent prior cancer therapy with the following exceptions

    • Patients who are receiving Sandostatin for treatment of Neuroendocrine cancer may be enrolled and continue their Sandostatin treatment.
    • Patients receiving anti-oestrogen therapy for breast cancer may continue their treatment if therapy was initiated greater than 30 days prior to TheraSphere treatment.
    • Chemotherapy may continue if there is evidence of progression, in the liver, on treatment providing there is no change in the therapy in the 1 month prior to TheraSphere treatment and any immediate chemotherapeutic toxicity that will complicate TheraSphere treatment is resolved. In this case, the chemotherapy may continue because it is continuing to control the extrahepatic disease.
  • Patient is willing to participate in the study and has signed the study informed consent

Exclusion Criteria

  • At risk of hepatic or renal failure, as indicated by any of the following pre-treatment laboratory and clinical findings within 28 days of treatment:

    • Serum creatinine > 2.0 mg/dL, unless on dialysis
    • Serum total bilirubin ≥ 2.0 mg/dL
    • Albumin < 2.0 g/dL
    • Any history of hepatic encephalopathy
  • Contraindications to angiography and selective visceral catheterization that may include, but are not limited to, the following:

    • Any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g., closure device)
    • Severe peripheral vascular disease precluding catheterization
    • History of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically.
  • Severe liver dysfunction or presentation of pulmonary insufficiency or a clinically evident history of chronic obstructive pulmonary disease
  • Cirrhosis or portal hypertension
  • Previous external beam radiation treatment to the liver
  • Any intervention for, or compromise of the Ampulla of Vater
  • Clinically evident ascites. (Note: A radiographic finding of trace ascites on imaging is acceptable).
  • Any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before the first treatment with TheraSphere (if the investigator determines that the continuing complication will compromise the safety of the patient following treatment with TheraSphere).
  • In the judgment of the physician, significant life-threatening extrahepatic disease
  • Concurrent enrollment in another clinical study
  • Evidence on technetium-99m macroaggregated albumin (99mTc-MAA) scan that demonstrates lung shunting with a potential absorbed dose of radiation to the lungs >30 Gy. The 30 Gy limit is a cumulative limit over all infusions of TheraSphere.
  • Evidence on technetium-99m macroaggregated albumin (99mTc-MAA) scan that demonstrates a potential for the deposition of microspheres to the gastrointestinal tract that cannot be corrected by placement of the catheter distal to collateral vessels or using standard angiographic techniques, such as coil embolization.
  • A positive serum pregnancy test in women of childbearing potential
  • In the Investigator's judgment, any co-morbid disease or condition or event (e.g., recent myocardial infarction) that would place the patient at undue risk, and that would preclude safe use of TheraSphere
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177007

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287-4010
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Jeff Geschwind, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01177007     History of Changes
Other Study ID Numbers: J09150, NA_00035790, J09150
Study First Received: August 2, 2010
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue
Liver Diseases
Neoplasms
Carcinoma
Colorectal Neoplasms
Neoplasm Metastasis
Carcinoma, Neuroendocrine
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 18, 2014