Clinical trial NCT02097875: Safety Study of a Fluorescent Marker to Visualize Cancer Cells
Official title: A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Skin Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Neoplasms
Keywords: Skin cancer
Basal cell carcinoma
Squamous cell carcinoma
Melanoma
Lead sponsor: Blaze Bioscience Australia Pty Ltd
Sponsor class: INDUSTRY
First posted: 2014-03-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Within at least 1 week from baseline
Secondary outcomes:
measure: Change in concentration of BLZ-100 in the blood
timeFrame: Prior to dosing and 1, 5, 15, 30, 60 and 90 minutes and 2, 3, 4, 6, 8, 12 and 24 hours post-dose
measure: Determination of a dose level for Phase 2 studies
timeFrame: At end of study - approximately 14 months
Other outcomes:
measure: Change in fluorescence signal in urine
timeFrame: Prior to dosing and at 0-4, 4-8, 8-12, 12-24 and 24-48 hours post-dose
measure: Change in fluorescent signal in skin tumor and normal skin
timeFrame: Prior to dosing on day 1 and at 2, 4, 24 and 48 hours post-dose
measure: Expression of biomarkers of response in excised skin tumor
timeFrame: 48 hours post-dose
Locations:
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
Study officials:
affiliation: Veracity Clinical Research Pty Ltd
name: Lynda Spelman, MBBS FACD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamada M, Miller DM, Lowe M, Rowe C, Wood D, Soyer HP, Byrnes-Blake K, Parrish-Novak J, Ishak L, Olson JM, Brandt G, Griffin P, Spelman L, Prow TW. A first-in-human study of BLZ-100 (tozuleristide) demonstrates tolerability and safety in skin cancer patients. Contemp Clin Trials Commun. 2021 Aug 4;23:100830. doi: 10.1016/j.conctc.2021.100830. eCollection 2021 Sep.