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

Phase 2
18 Years
Open (Enrolling)
Liver Neoplasms

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Trial Information

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

Inclusion 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

- 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

- 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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression (TTP) of the treated lesion(s) according to RECIST criteria

Outcome Time Frame:

Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.

Safety Issue:


Principal Investigator

Jeff Geschwind, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Food and Drug Administration

Study ID:

J09150, NA_00035790



Start Date:

September 2010

Completion Date:

June 2014

Related Keywords:

  • Liver Neoplasms
  • 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
  • Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis



Johns Hopkins Hospital Baltimore, Maryland  21287