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Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver

Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients With Metastatic Breast Cancer to the Liver

NCT00301106•Max Sung

View on ClinicalTrials.gov

Summary

RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast cancer that has spread to the liver.

Detailed Description

Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene (Adv.RSV-hIL12, also termed ADV-hIL-12). OBJECTIVES: * Study the toxicity of escalating doses of adenoviral vector expressing the human recombinant interleukin-12 gene, administered by percutaneous intratumoral injection, in women with liver metastasis secondary to breast cancer. * Determine tumor responses produced by this regimen. * Determine immune responses induced by this regimen.

Eligibility

Age

18 - 85 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•DISEASE CHARACTERISTICS:
•Histologically or cytologically confirmed\* breast adenocarcinoma metastatic to the liver
•* Solitary or multiple hepatic metastases
•* No malignant involvement of \> 40% of the estimated liver volume NOTE: \*Must be from the hepatic tumor designated for study injection
•Metastatic liver tumors must be measurable in ≥ 2 dimensions on CT scan or MRI
•At least 1 metastatic hepatic tumor ≥ 2 cm in diameter must be visualized by ultrasound and accessible for percutaneous injection under ultrasound guidance
•Extrahepatic metastasis allowed
•No solitary hepatic metastasis eligible for liver resection
•No clinical evidence for severe liver disease (e.g., prior or current ascites or portosystemic encephalopathy)
•Hormone-receptor status not specified
+23 more criteria

Locations (1)

Mount Sinai Medical Center

New York, New York, United States

Key Dates

Start Date

October 1, 2005

Primary Completion Date

August 1, 2008

Completion Date

August 1, 2008

Last Updated

February 2, 2017

Enrollment

ACTUAL participants

Conditions

Breast CancerMetastatic Cancer

Interventions

adenovirus-mediated human interleukin-12

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver

Inclusion Criteria

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