Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02462629 : Study of BLZ-100 in Pediatric Subjects With CNS Tumors
PhasePhase 1
AgesMin: 1 Month Max: 30 Years
Eligibility
Inclusion Criteria:

1. Age: >1 month and <30 years at time of enrollment

2. Diagnosis: Must have MRI documenting a measurable lesion w/in central nervous system
consistent with primary central nervous system tumor, for which maximal safe surgical
resection is indicated

3. Timing of surgery: Must be anticipated to take place at least 1 hour after BLZ-100
administration

4. Prior therapy: Must have recovered from acute toxic effects of prior anti-cancer
therapy (durations relative to date of enrollment):

- Radiation therapy: may not have had radiation therapy to area of tumor planned to
be resected w/in 28 days

- Chemotherapy: ?14 days from any myelosuppressive chemotherapy and abs neutrophil
ct ?1000/mm3 , 42 days if prior nitrosurea

- Biologic: ?7 days from anti-neoplastic biologic agent

- Immunotherapy: ?42 days after completion of immunotherapy

- Monoclonal antibody: ?3 half-lives of antibody since last admin.

5. Organ function requirements:

- Adequate renal function defined as:

- serum creatinine w/in normal limits or

- calculated creatinine clearance > 100 mL/min/1.73 m2

- Adequate liver function defined as:

- bilirubin <2x upper limit of normal for age

- alanine aminotransferase <3x upper limit of normal for age (<135 U/mL)

- serum albumin >2g/dL

- Adequate coagulation defined as:

- no evidence of active/clinically significant bleeding. May be evidence of
punctate hemorrhage w/in tumor as long as not considered clinically
significant to warrant urgent surgical evacuation

- internal normalized ratio and partial thromboplastin time <1.5x upper limit
of normal

6. Informed Consent: Written informed consent must be obtained from subject or
parent/legal guardian prior to enrollment. Assent, when appropriate, will be obtained
according to institutional guidelines

Exclusion Criteria:

1. Pregnancy and contraception: Subjects who are pregnant, breast-feeding or planning to
conceive within 30 days are not eligible

2. Concomitant medications:

- Corticosteroids: no restrictions

- Investigational drugs: must not be receiving other investigational (from other
studies) drugs at time of enrollment and must not be planning to take other
investigational drugs during DLT period

- Anti-cancer agents: must not be receiving other anti-cancer agents at time of
enrollment and must not be planning to take other anti-cancer agents during DLT
period

- Anticoagulation: if currently receiving therapeutic anticoagulation with heparin,
low-molecular weight heparin, or Coumadin, not eligible

- Anti-platelet agents: if currently receiving aspirin, ibuprofen or other
non-steroidal anti-inflammatory or anti-platelet agents, not eligible

- Photosensitizing drugs, medications which might generate fluorescence or
according to label, might generate photochemical reaction. These include
hematoporphyrin derivatives and purified fractions; Photofrin®; and precursors of
protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix

- Subjects must not have received BLZ-100 within 30 days prior to re-treatment

3. Infection: Subjects with uncontrolled infection not eligible

4. Bleeding and Thrombosis:

- If active bleeding requiring acute surgical intervention, not eligible

- Subjects with stroke, arterial or venous thrombosis within 6 months not eligible

- Subjects requiring anticoagulation not eligible

5. Acuity of surgical needs: Subjects with acute neurologic compromise, symptoms of
impending cerebral herniation, or other condition(s) necessitating urgent or emergent
neurosurgical intervention to be planned within 2 hours not eligible. NOTE: If subject
is enrolled on study, receives study medication and subsequently condition worsens
such that urgent surgical intervention is felt to be in best interest of subject, best
interest of subject should always take precedence over timing between study medication
and surgery

6. Required observations: Subjects who in opinion of investigator may not be able to
comply with required safety and monitoring requirements are not eligible
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02462629      |      Link to official Clinicaltrials.gov listing
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