Gene Therapy in Treating Women With Metastatic Breast Cancer

Phase 1

Completed

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

• Registration Number: NCT00849459
• Lead Sponsor: Max Sung

Brief Summary

RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in treating women with metastatic breast cancer.

Detailed Description

OBJECTIVES:

* Determine the toxicity and maximum tolerated dose of intratumoral injection of adenovirus-mediated human interleukin-12 gene in women with metastatic breast cancer.

* Determine the tumor response in patients treated with this regimen.

* Determine the immune response in patients treated with this regimen.

OUTLINE: Patients receive a single dose of adenovirus-mediated human interleukin-12 intratumorally via percutaneous needle placement under ultrasound guidance.

Blood and tumor tissue samples are collected periodically for immunological laboratory studies. Samples are analyzed for serum cytokine levels by ELISA; qualitative analysis of immune biomarkers by IHC staining; and immune cell biomarker analysis by FACS.

After completion of study therapy, patients are followed periodically.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-23
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3

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
Maximum tolerated dose	up to 1 month	Serum antibodies (titer) to adenovirus
Toxicity and safety	up to 2 months	adverse events as assessed by NCI CTCAE v3.0

Secondary Outcome Measures

Name	Time	Method
Tumor response progression)	up to 2 months	Sequential assessment of tumor on CT or MRI (complete response, partial response, stable disease, or disease)
Immune response	up to 2 months	Serum IL12, and IFNγ levels. Serum antibodies (titer) to adenovirus.

Trial Locations

Locations (1)

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