Gene Therapy in Treating Women With Metastatic Breast Cancer

NCT00849459 | Completed Phase 1 DMC

• 4 other identifiers: GCO 02-0797MTS-GCO-02-0797NIH-0707-869CDR0000629819
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  Serum antibodies (titer) to adenovirus

  up to 1 month

• Toxicity and safety

  adverse events as assessed by NCI CTCAE v3.0

  up to 2 months

Secondary Outcomes (2)

• Tumor response progression)

  up to 2 months

• Immune response

  up to 2 months

Study Arms (1)

adenovirus-mediated human interleukin-12

EXPERIMENTAL

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.

Biological: adenovirus-mediated human interleukin-12

Interventions

adenovirus-mediated human interleukin-12 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.

adenovirus-mediated human interleukin-12

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Max Sung: lead

Study Sites (1)

Icahn Medical Center at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Max W. Sung, MD

  Icahn Medical Center at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 23, 2009
• Study Start: August 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

US (1)