Gene Therapy in Treating Women With Metastatic Breast Cancer

NCT ID: NCT00849459

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-06-30

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.

Conditions

Breast 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

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

• Minimum Eligible Age: 18 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: PRINCIPAL_INVESTIGATOR

Icahn Medical Center at Mount Sinai

Locations

Icahn Medical Center at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

MTS-GCO-02-0797

Identifier Type: -

Identifier Source: secondary_id

NIH-0707-869

Identifier Type: -

Identifier Source: secondary_id

CDR0000629819

Identifier Type: -

Identifier Source: secondary_id

GCO 02-0797

Identifier Type: -

Identifier Source: org_study_id