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| Name | Class |
|---|---|
| The Alfred | OTHER |
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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 developed to increase the amount of oxygen delivered to tumors which is hoped to increase the effectiveness of radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | NVX-108 (DDFP liquid emulsion) i.v. in conjunction with Radiation Treatment and Temozolimide. 0.05-0.35cc/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVX-108 | Drug | 0.2% emulsion administered i.v. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of NVX-108 in Combination with Radiation and Temozolomide Defined by no Drug related Adverse Events (AE) in No More than 1 Patient per Treatment Group | Adverse Events are considered to be neurological and hemodynamic | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Reduction Based on Gd-MRI | First determination will be measured at 4 months | 4 months |
Inclusion Criteria:
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 Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Lickliter, MBBSPhDFRACP | Nucleus Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincents Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia | ||
| Flinders Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37609003 | Derived | Lickliter JD, Ruben J, Kichenadasse G, Jennens R, Gzell C, Mason RP, Zhou H, Becker J, Unger E, Stea B. Dodecafluoropentane Emulsion as a Radiosensitizer in Glioblastoma Multiforme. Cancer Res Commun. 2023 Aug 21;3(8):1607-1614. doi: 10.1158/2767-9764.CRC-22-0433. eCollection 2023 Aug. |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| C008806 | perfluoropentane |
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| Adelaide |
| South Australia |
| 5042 |
| Australia |
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
| Epworth Center | Melbourne | Victoria | 3121 | Australia |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |