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

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ClinicalTrials.gov Identifier: NCT00301106
Recruitment Status : Terminated (protocol underwent significant revisions, decision made to terminate study and open as new study listed NCT00849459)
First Posted : March 10, 2006
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Max Sung, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE March 8, 2006
First Posted Date  ICMJE March 10, 2006
Last Update Posted Date February 2, 2017
Study Start Date  ICMJE October 2005
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
Toxicity [ Time Frame: up to 15 days ]
Serial monitoring of tumor necrosis factor alpha (TNFα) levels
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
  • Tumor Response [ Time Frame: up to 2 months ]
    Sequential assessment of tumor on CT or MRI
  • IL12 level Immune response [ Time Frame: up to 2 months ]
    Serum IL12 level
  • IFNγ levels Immune response [ Time Frame: up to 2 months ]
    IFNγ levels
  • Immune response [ Time Frame: up to 2 months ]
    Serum antibodies (titer) to adenovirus.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
Official Title  ICMJE 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
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.
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
  • Metastatic 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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 31, 2017)
2
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 85 Years   (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 NCT00301106
Other Study ID Numbers  ICMJE GCO 97-779
MTS-GCO-97-779
MTS-9911-358
MTS-A-8200
CDR0000456626
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
Study Chair: Max W. Sung, MD Icahn School of Medicine 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