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Gene Therapy in Treating Women With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00849459
Recruitment Status : Completed
First Posted : February 23, 2009
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Max Sung, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE February 20, 2009
First Posted Date  ICMJE February 23, 2009
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE August 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • Maximum tolerated dose [ Time Frame: up to 1 month ]
    Serum antibodies (titer) to adenovirus
  • Toxicity and safety [ Time Frame: up to 2 months ]
    adverse events as assessed by NCI CTCAE v3.0
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2009)
  • Maximum tolerated dose
  • Toxicity and safety as assessed by NCI CTCAE v3.0
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2017)
  • Tumor response progression) [ Time Frame: up to 2 months ]
    Sequential assessment of tumor on CT or MRI (complete response, partial response, stable disease, or disease)
  • Immune response [ Time Frame: up to 2 months ]
    Serum IL12, and IFNγ levels. Serum antibodies (titer) to adenovirus.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2009)
  • Tumor response (complete response, partial response, stable disease, or disease progression)
  • Immune response
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gene Therapy in Treating Women With Metastatic Breast Cancer
Official Title  ICMJE Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patents With Metastatic Breast Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: 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.
Intervention: Biological: adenovirus-mediated human interleukin-12
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2009)
36
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00849459
Other Study ID Numbers  ICMJE GCO 02-0797
MTS-GCO-02-0797
NIH-0707-869
CDR0000629819
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Max Sung, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Max Sung
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Max W. Sung, MD Icahn Medical Center at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP