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Safety Study of a Fluorescent Marker to Visualize Cancer Cells

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ClinicalTrials.gov Identifier: NCT02097875
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Blaze Bioscience Australia Pty Ltd

Brief Summary:
Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in incomplete removal of the tumor and reduced patient survival. In addition, in some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on function. We hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time, as they operate.

Condition or disease Intervention/treatment Phase
Skin Neoplasms Drug: BLZ-100 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Skin Cancer
Study Start Date : December 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
Experimental: BLZ-100
A single dose of BLZ-100 (1, 3, 6, 12 or 18 mg) will be administered by intravenous injection approximately 48 hours prior to planned excision of skin tumor.
Drug: BLZ-100



Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Within at least 1 week from baseline ]
    Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.


Secondary Outcome Measures :
  1. Change in concentration of BLZ-100 in the blood [ Time Frame: Prior to dosing and 1, 5, 15, 30, 60 and 90 minutes and 2, 3, 4, 6, 8, 12 and 24 hours post-dose ]
    BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.

  2. Determination of a dose level for Phase 2 studies [ Time Frame: At end of study - approximately 14 months ]

Other Outcome Measures:
  1. Change in fluorescence signal in urine [ Time Frame: Prior to dosing and at 0-4, 4-8, 8-12, 12-24 and 24-48 hours post-dose ]
    Fluorescence signal in urine samples will be measured using an infrared imaging system to determine the amount of BLZ-100 being excreted in the urine post-dosing.

  2. Change in fluorescent signal in skin tumor and normal skin [ Time Frame: Prior to dosing on day 1 and at 2, 4, 24 and 48 hours post-dose ]
    Fluorescence signal in skin tumor and normal skin will be measured in situ using the Fluobeam(TM) infrared imaging system.

  3. Expression of biomarkers of response in excised skin tumor [ Time Frame: 48 hours post-dose ]
    Immunohistochemistry will be used to measure the expression of other biomarkers of response, including Annexin A2, Ki67 and MMP2 (matrix metalloproteinase-2), in normal and tumor tissue.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients age ≥ 18 years.
  • Known or suspected non-metastatic basal cell or squamous cell carcinomas ≥10 mm longest diameter or non-metastatic melanoma ≥6 mm longest diameter scheduled for excision, without advanced disease.
  • Written Informed Consent.
  • Agree to the use of effective contraceptive from Baseline and for 30 days after treatment if either male or female of child bearing potential.
  • Available for and able to comply with study requirements.

Exclusion Criteria:

  • Women who are lactating/breastfeeding
  • Women with a positive pregnancy test or who are planning to become pregnant during the duration of the study.
  • Life expectancy <6 months.
  • Karnofsky Performance Status of ≤70%.
  • The following laboratory abnormalities:

    • Neutrophil count <1.5 x 10^9/L
    • Platelets <75 x 10^9/L
    • Haemoglobin <10 g/dL (may be determined following transfusion)
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal (ULN)
    • Total bilirubin >2x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
    • International Normalized Ratio (INR) >1.5
    • Creatinine >1.5x ULN
  • History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine and/or hospitalization.
  • Uncontrolled asthma or asthma requiring oral corticosteroids.
  • Clinically significant chronic inflammatory skin conditions, including psoriasis, atopic dermatitis and scleroderma, as determined by the investigator.
  • Unstable angina, myocardial infarction, known or suspected transient ischemic events or stroke within 24 weeks of Screening.
  • Uncontrolled hypertension.
  • QTc (corrected QT interval) prolongation >450 msec.
  • Receipt of photosensitising drugs within 30 days of screening.
  • Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
  • Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data.
  • Known or suspected sensitivity to study product or excipients.
  • Prior participation in this clinical trial (has received study product).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097875


Locations
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Australia, Queensland
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia, 4102
Sponsors and Collaborators
Blaze Bioscience Australia Pty Ltd
Investigators
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Principal Investigator: Lynda Spelman, MBBS FACD Veracity Clinical Research Pty Ltd

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Responsible Party: Blaze Bioscience Australia Pty Ltd
ClinicalTrials.gov Identifier: NCT02097875     History of Changes
Other Study ID Numbers: BB-001
ACTRN12614000115639 ( Registry Identifier: ANZCTR )
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by Blaze Bioscience Australia Pty Ltd:
Skin cancer
Basal cell carcinoma
Squamous cell carcinoma
Melanoma

Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases