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

Liver Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01177007
• Other study ID #: J09150, NA_00035790
• Secondary ID: J09150
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 2, 2010
• Last updated: August 6, 2014
• Start date: September 2010
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression (TTP) of the treated lesion(s) according to RECIST criteria		Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.	No
Secondary	Time to progression (TTP) of the treated lesion(s) according to EASL criteria		Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.	No
Secondary	Overall Survival (OS)	Measured from the date corresponding to initiation of therapy until the date of death due to any cause.	open-ended	No
Secondary	Safety as graded by CTCAE version 3.0		Evaluated at 2 and 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.	Yes