Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery

NCT02464332 | Withdrawn Phase 1 DMC

• 2 other identifiers: BB-003261201400046C-0-0-1
• Study Type: interventional
• Target: N/A
• 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, and failure to surgically remove a cancer-affected lymph node or residual cancer at the surgical margin reduces a patient's chance of survival. Moreover, damage to adjacent normal tissue during surgery can result in significant morbidity. The investigators 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. This is a safety study to assess the safety of BLZ-100 in patients with soft tissue sarcoma undergoing surgery.

Conditions

Sarcoma, Soft Tissue

Keywords

soft tissue sarcoma; BLZ-100; Tumor Paint

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.

  Seven days after study drug administration

Secondary Outcomes (3)

• Change of concentration of BLZ-100 in the blood

  Prior to dosing and at 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes and 120 minutes after end of injection, and pre-surgery and 24 hours post-surgery

• Fluorescence signal from areas of tumor and non-tumor

  1 day post-dose, 2-3 days post-dose, or 3-7 days post-dose

• Ideal combination of dose and imaging interval

  1 day post-dose, 2-3 days post-dose, 3-7 days post-dose

Study Arms (1)

BLZ-100

EXPERIMENTAL

All participants in the study will receive the investigational drug product BLZ-100. In part 1 of the study, two dose levels of BLZ-100 will be evaluated (3 mg and 12 mg) in 6 subjects, with a 2-3 post-dose imaging window. In part 2 of the study up to 15 additional subjects will be randomized to one of three imaging interval groups (up to 6 subjects/interval): Early Imaging (within 1 day post-BLZ-100 dose), Intermediate Imaging (2 - 3 days post- BLZ-100 dose), and Late Imaging (4 - 7 days post- BLZ-100 dose).

Drug: BLZ-100

Interventions

BLZ-100 DRUG

All subjects enrolled in the study will receive doses of BLZ-100, an investigational drug for imaging tumors. Three different imaging windows will be investigated during the study: Early Imaging (imaging occurs within 1 day post-BLZ-100 dose); Intermediate Imaging (imaging occurs within 2-3 days post-BLZ-100 dose); Late Imaging (imaging occurs 4-7 post-BLZ-100 dose) All subjects in Part 1 of the study will be imaged in the Intermediate Imaging group. Subjects in Part 2 of the study will be randomized into one of the three imaging groups.

Also known as: Tumor Paint

BLZ-100

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male of female subject aged 18-75 years
• Diagnosis of soft tissue sarcoma, with scheduled surgical removal for treatment for the disease and completion of chemotherapy or radiation within 4 weeks of BLZ-100 administration
• Able to provide written informed consent
• If of child-bearing potential, agree to continued use of two reliable methods of contraceptive from study entry (time of informed consent) through 30 days after BLZ-100 administration
• Available for all study visits and able to comply with all study requirements

You may not qualify if:

• Clinically-suspected and/or pathologically-confirmed sarcoma of the bone (e.g. osteosarcoma, Ewing's sarcoma with bony involvement, chondrosarcoma, Kaposi's sarcoma, extraosseous primitive neuroectodermal tumor \[PNET\])
• Evidence of metastatic disease
• Female who is lactating/breastfeeding
• Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study
• Karnofsky Performance Status of \<60%
• Any of the following laboratory abnormalities at Screening:
• Neutrophil count \<1.5 x 10\^9/L
• Platelets \<75 x 10\^9/L
• Hemoglobin \<10 g/dL (may be determined following transfusion)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3x upper limit of normal (ULN)
• Total bilirubin \>1.5x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
• Internal Normalized Ratio (INR) \>1.5
• Creatinine \>1.5x ULN
• Calculated estimated glomerular filtration rate (eGFR) ≤60 mL/min
• Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)

Sponsors & Collaborators

• Blaze Bioscience Inc.: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

tozuleristide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Charles Forscher, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 8, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 26, 2016

Record last verified: 2016-05

Locations

US (1)