Gene Therapy in Treating Women With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849459
• Other study ID #: GCO 02-0797
• Secondary ID: MTS-GCO-02-0797N
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2009
• Last updated: January 10, 2017
• Start date: August 2008
• Est. completion date: June 2011

Study information

• Verified date: January 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic adenocarcinoma of the breast

• Malignant disease in the skin, chest wall, or other sites (lymph nodes or primary tumor in the breast) accessible to percutaneous needle placement and injection

• Solitary or multiple tumors

• Measurable disease in = 2 dimensions by physical examination or CT/MRI scan

• Malignant tumors in the skin and chest wall must be = 4 mm in diameter by physical examination

• Malignant tumors in other accessible sites must be = 1 cm in diameter on physical examination

• Malignant disease in other organs (in addition to skin or chest wall metastases) allowed

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• Karnofsky performance status 70-100%

• Life expectancy = 16 weeks

• Granulocyte count = 1,500/mm^3

• Platelet count = 100,000/mm^3

• Hemoglobin = 9.0 mg/dL

• PT normal

• Serum creatinine = 1.5 mg/dL OR creatinine clearance = 45 mL/min

• Serum total bilirubin = 2.0 times upper limit of normal (ULN)

• Serum transaminases = 2.5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Weight = 30 kg (for patients treated with the highest dose level of study drug)

• No active infection or concurrent serious medical illness

• No HIV positivity

• No other malignancy within the past 5 years except for the following:

• Inactive nonmelanoma skin cancer

• In situ carcinoma of the cervix

• Grade 1 papillary bladder cancer

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

• No anticoagulant therapy with heparin or warfarin for = 2 months after completion of study treatment

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• adenovirus-mediated human interleukin-12
The purified ADV-hIL12 is suspended in formulation buffer (10mM Tris, pH 7.5/ 1mM MgCl2/ 150mM NaCl/ 10% glycerol) and aliquoted into 1ml cryovials. The filled vials are stored at or below -60 degC.

Locations

Country	Name	City	State
United States	Icahn Medical Center at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Max Sung

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose	Serum antibodies (titer) to adenovirus	up to 1 month	Yes
Primary	Toxicity and safety	adverse events as assessed by NCI CTCAE v3.0	up to 2 months	Yes
Secondary	Tumor response progression)	Sequential assessment of tumor on CT or MRI (complete response, partial response, stable disease, or disease)	up to 2 months	No
Secondary	Immune response	Serum IL12, and IFN? levels. Serum antibodies (titer) to adenovirus.	up to 2 months	No