Safety Study of BLZ-100 in Adult Subjects With Glioma Undergoing Surgery
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | October 2014 |
| End Date: | March 2016 |
A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Glioma Undergoing Surgery
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.
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.
Subjects who provide voluntary written informed consent will be screened for eligibility.
Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to
participate.
Subjects will be required to arrive at the hospital (or phase 1 unit if applicable) for
dosing at least 2 hours before the planned surgical excision. Following dosing, subjects
will be monitored for safety and surgical excision will occur at least 2 hours after study
product administration.
Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to
participate.
Subjects will be required to arrive at the hospital (or phase 1 unit if applicable) for
dosing at least 2 hours before the planned surgical excision. Following dosing, subjects
will be monitored for safety and surgical excision will occur at least 2 hours after study
product administration.
Inclusion Criteria:
1. Male or female subjects aged 18- 75 years.
2. 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.
3. Able to provide written informed consent.
4. 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.
5. Available for all study visits and able to comply with all study requirements
Exclusion Criteria:
1. Evidence of metastatic disease.
2. Female who is lactating/breastfeeding
3. Female with a positive pregnancy test or who is planning to become pregnant during
the duration of the study.
4. Karnofsky Performance Status of <60%.
5. Any of the following laboratory abnormalities at Screening:
1. Neutrophil count <1.5 x 10^9/L
2. Platelets <75 x 10^9/L
3. Hemoglobin <10 g/dL (may be determined following transfusion)
4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x upper
limit of normal (ULN)
5. Total bilirubin >1.5x upper limit of reference range (unless Gilbert's syndrome
or extrahepatic source as denoted by increased indirect bilirubin fraction)
6. International Normalized Ratio (INR) >1.5
7. Creatinine >1.5x ULN
6. Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or
hepatitis B virus (HBV).
7. QTc prolongation >450 msec
8. History of hypersensitivity or allergic reactions requiring corticosteroids,
epinephrine and/or hospitalization.
9. Uncontrolled asthma or asthma requiring oral corticosteroids.
10. Known or suspected sensitivity to MRI contrast agents or excipients in the study drug
product.
11. Known or suspected sensitivity to Indocyanine green (ICG).
12. Unstable angina, myocardial infarction, known or suspected transient ischemic events
or stroke within 24 weeks of start of Screening.
13. Uncontrolled hypertension.
14. Receipt of photosensitizing drugs within 30 days of Screening.
15. Any ongoing medications which might generate fluorescence or according to label,
might generate a photochemical reaction. These include haematoporphyrin derivatives
and purified fractions; Photofrin®; and the precursors of protoporphyrin IX
(5-Aminolevulinic acid) used in Gliolan or Hexvix.
16. Received an investigational drug or device within 30 days of enrollment.
17. Prior treatment with BLZ-100.
18. 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.
We found this trial at
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