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

Phase 1

Terminated

• Conditions: Breast Cancer; Metastatic Cancer
• Interventions: Biological: adenovirus-mediated human interleukin-12

• Registration Number: NCT00301106
• Lead Sponsor: Max Sung

Brief 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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-03-08
• Study First Submitted QC: 2006-03-08
• Study First Posted: 2006-03-10
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adenovirus-mediated human interleukin-12	adenovirus-mediated human interleukin-12	starting dose of ADV-hIL12 - 1 x 10 to the 10th power vp (virus particles) per patient, escalating in half-log increments up to 1 x 10 to the 13th power vp per patient, after which dose escalation will be at lower increments of 2 x 10 to the 13th power vp, to a maximum of 3.0 x 10 to the 13th power vp per patient.

Primary Outcome Measures

Name	Time	Method
Toxicity	up to 15 days	Serial monitoring of tumor necrosis factor alpha (TNFα) levels

Secondary Outcome Measures

Name	Time	Method
IL12 level Immune response	up to 2 months	Serum IL12 level
Tumor Response	up to 2 months	Sequential assessment of tumor on CT or MRI
IFNγ levels Immune response	up to 2 months	IFNγ levels
Immune response	up to 2 months	Serum antibodies (titer) to adenovirus.

Trial Locations

Locations (1)

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States