Status:
COMPLETED
The Effects of NVX-108 as a Radiation Sensitizer in Glioblastoma
Lead Sponsor:
NuvOx LLC
Collaborating Sponsors:
The Alfred
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This clinical trial is testing the safety, tolerability and effectiveness of NVX-108 administered via intravenous infusion in combination with standard radiation and chemotherapy. NVX-108 is being de...
Eligibility Criteria
Inclusion
- Histologically-confirmed newly-diagnosed glioblastoma multiforme.
- No prior treatment for glioblastoma apart from surgical resection.
- No prior treatment for glioblastoma apart from surgical resection.
- Planned for 60 Gray of focal radiation administered in 30 fractions, concurrently with temozolomide chemotherapy.
- Manageable risks associated with potential radiation necrosis in the radiation field, based on size of the field and proximity to eloquent brain regions (as assessed by the investigator).
- Aged 18-70 years.
- ECOG performance status 0-2.
- Life expectancy of at least 3 months.
- If receiving glucocorticoid therapy, the dose must be stable over at least 7 days prior to study enrollment.
- Archived tumor tissue available for central review.
- Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans.
- Baseline MRI performed within 14 days before starting study treatment, while on a stable glucocorticoid dose for at least 5 days before and during the imaging study.
- Adequate hematologic, renal and hepatic function, as defined by:
- Absolute neutrophil count (ANC) ≥ 1.5 109/L Platelet count ≥ 100 109/L Hemoglobin ≥ 90 g/L International normalized ratio (INR) and activated partial thromboplastin time (APTT) \< 1.5 upper limit of normal (ULN) Plasma creatinine\< 1.5 ULN Total bilirubin within normal limits (\< 2.5 ULN if Gilbert's syndrome) AST and ALT \< 2.5 ULN
- Patients who are women of childbearing potential or men (unless vasectomised) must agree to use a highly-effective method of birth control, such as hormonal contraceptive implants, combined oral contraceptives, an intrauterine device, a double-barrier method (eg. condom with a diaphragm) or abstinence, from study entry until 4 months after completing study therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Presence of leptomeningeal disease or multifocal glioblastoma that cannot be encompassed within a feasible and safe radiation field.
- Intracranial bleeding, except for stable grade 1 hemorrhage.
- Has not recovered from the adverse effects of surgical resection or biopsy, except for neurological deficits.
- Patients who have received any other investigational agent within 4 weeks before enrollment.
- Stroke or transient ischemic attack within 6 months before enrollment.
- Myocardial infarction within 6 months before enrollment, unstable angina, New York Heart Association class II or greater congestive heart failure, or uncontrolled hypertension (systolic BP \> 160 mmHg and/or diastolic BP \> 100 mmHg).
- Congenital long QT syndrome.
- Clinically-significant chronic obstructive pulmonary disease or asthma.
- Active major infection requiring treatment.
- A history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.
- Known infection with human immunodeficiency virus or hepatitis B or C virus.
- Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low molecular weight heparins or low-dose aspirin.
- History of allergic reactions attributed to compounds of similar chemical composition to NVX-108.
- Women who are pregnant or breast feeding.
- Inability to comply with study procedures.
- History or evidence of any other clinically-significant condition that, in the opinion of the investigator, would pose a risk to subject safety or interfere with study procedures, evaluation or completion.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02189109
Start Date
May 1 2014
End Date
April 1 2018
Last Update
February 28 2019
Active Locations (4)
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1
St. Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
2
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
3
Nucleus Network
Melbourne, Victoria, Australia, 3004
4
Epworth Center
Melbourne, Victoria, Australia, 3121