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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00301106
• Other study ID #: GCO 97-779
• Secondary ID: MTS-GCO-97-779MT
• Status: Terminated
• Phase: Phase 1
• First received: March 8, 2006
• Last updated: January 31, 2017
• Start date: October 2005
• Est. completion date: August 2008

Study information

• Verified date: January 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

PATIENT CHARACTERISTICS:

• Female

• Menopausal status not specified

• Granulocyte count = 1,500/mm^3

• Hemoglobin = 9.0 g/dL

• Platelet count = 100,000/mm^3

• PT = 14.5 sec

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

• Bilirubin = 2 times upper limit of normal (ULN)

• Transaminases = 2.5 times ULN

• Karnofsky performance status = 70%

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 2 months after completion of study treatment

• No active infection or serious intercurrent medical illness

• No HIV infection

• Life expectancy = 16 weeks

• No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, or grade 1 papillary bladder cancer

• At highest dose level, patient must weigh = 30 kg

PRIOR CONCURRENT THERAPY:

• No systemic immunosuppressive drugs, including corticosteroids, within 2 months prior to study entry

• Not require immunosuppressive drugs or anticoagulant therapy with heparin or warfarin for at least 2 months after study treatment

• No chemotherapy within 4 weeks of study entry (6 weeks for nitrosoureas)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

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	Mount Sinai Medical Center	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	Toxicity	Serial monitoring of tumor necrosis factor alpha (TNFa) levels	up to 15 days
Secondary	Tumor Response	Sequential assessment of tumor on CT or MRI	up to 2 months
Secondary	IL12 level Immune response	Serum IL12 level	up to 2 months
Secondary	IFN? levels Immune response	IFN? levels	up to 2 months
Secondary	Immune response	Serum antibodies (titer) to adenovirus.	up to 2 months