NCT02234297

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 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 operate. This is a safety study to assess the safety of BLZ-100 in patients with gliomas undergoing surgery.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2014

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

August 4, 2014

Last Update Submit

April 4, 2016

Conditions

Glioma

Keywords

GliomaTumor PaintBLZ100

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 (1)

  • Change in concentration of BLZ-100 in the blood

    Prior to dosing and at 1 minute, 5 minutes, 15 mins, 30 mins, 60 mins and 120 mins after end of injection

Other Outcomes (1)

  • Fluoresence signal in excised brain tumor and normal brain cancer

    at least 2 hours post-dose

Study Arms (1)

BLZ-100

EXPERIMENTAL
Drug: BLZ-100

Interventions

BLZ-100DRUG
Also known as: Tumor Paint
BLZ-100

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects aged 18- 75 years.
  • Subjects must have glioma for which surgical resection is clinically indicated. Grade I, II, III and IV glioma patients will be included (for example glioblastoma, astrocytoma, and oligodendroglioma). Histological confirmation not required prior to surgery. Subjects with recurrent disease will be eligible only if the duration between last brain surgery and scheduled new surgery is ≥3 months. The grade of a recurrent tumor will be presumed that of the primary tumor for purposes of group allocation.
  • Able to provide written informed consent.
  • If of child-bearing potential, agree to the continued use of effective contraceptive from study entry (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:

  • 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)
  • International Normalized Ratio (INR) \>1.5
  • Creatinine \>1.5x ULN
  • Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
  • QTc prolongation \>450 msec
  • History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine and/or hospitalization.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

NEWRO Foundation

Brisbane, Queensland, Auchenflower, Australia

Location

MeSH Terms

Conditions

Glioma

Interventions

tozuleristide

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Chirag Patil

    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

August 4, 2014

First Posted

September 9, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

US(1)AU(1)