Safety Study of a Fluorescent Marker to Visualize Cancer Cells

NCT02097875 | Completed Phase 1

• 2 other identifiers: BB-001ACTRN12614000115639
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Neoplasms

Keywords

Skin cancer; Basal cell carcinoma; Squamous cell carcinoma; Melanoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.

  Within at least 1 week from baseline

Secondary Outcomes (2)

• Change in concentration of BLZ-100 in the blood

  Prior to dosing and 1, 5, 15, 30, 60 and 90 minutes and 2, 3, 4, 6, 8, 12 and 24 hours post-dose

• Determination of a dose level for Phase 2 studies

  At end of study - approximately 14 months

Other Outcomes (3)

• Change in fluorescence signal in urine

  Prior to dosing and at 0-4, 4-8, 8-12, 12-24 and 24-48 hours post-dose

• Change in fluorescent signal in skin tumor and normal skin

  Prior to dosing on day 1 and at 2, 4, 24 and 48 hours post-dose

• Expression of biomarkers of response in excised skin tumor

  48 hours post-dose

Study Arms (1)

BLZ-100

EXPERIMENTAL

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

Interventions

BLZ-100 DRUG

BLZ-100

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blaze Bioscience Australia Pty Ltd: lead

Study Sites (1)

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, 4102, Australia

Location

Related Publications (1)

• 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.

  PMID: 34401600 DERIVED

MeSH Terms

Conditions

Skin Neoplasms; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Melanoma

Interventions

tozuleristide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Neoplasms, Squamous Cell; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas

Study Officials

• Lynda Spelman, MBBS FACD

  Veracity Clinical Research Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 27, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

AU (1)