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

NCT ID: NCT00301106

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-08-31

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.

Conditions

Breast Cancer; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

adenovirus-mediated human interleukin-12

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Max Sung

OTHER

Sponsor Role: lead

Responsible Party

Max Sung

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Max W. Sung, MD

Role: STUDY_CHAIR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

MTS-GCO-97-779

Identifier Type: -

Identifier Source: secondary_id

MTS-9911-358

Identifier Type: -

Identifier Source: secondary_id

MTS-A-8200

Identifier Type: -

Identifier Source: secondary_id

CDR0000456626

Identifier Type: -

Identifier Source: secondary_id

GCO 97-779

Identifier Type: -

Identifier Source: org_study_id