Intervention: Paclitaxel
Trial phase: Phase 1 | Phase 2
ATC code: L01CD01 | L01CD51
SMILES: CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel

OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.
Eligibility criteria:
Inclusion Criteria:

At least 18 to less than 70 years of age
Radiological evidence on MRI of progressive recurrent malignant glioma that is unilateral, unifocal, supratentorial and of the minimum tumor volume as required per dose level assignment
Tumor must have a solid contrast enhancing component
Gross total resection >95% of the recurrence must be planned
Must have received prior conventional radiation therapy completed >4 weeks before Study Day 1 (ie, day of craniotomy and OncoGel administration)
Previous cytoreductive surgery or biopsy with pathologic diagnosis of glioblastoma multiforme
Diagnosis of glioma at the time of debulking surgery for recurrence (by frozen section or squash preparation)
Life expectancy > 2 months
KPS greater than or equal to 70
Using appropriate birth control, if female of child-bearing potential;
Able and willing to participate in the study by signing the informed consent document

Exclusion Criteria:

Contrast-enhancing tumor crossing the midline
Multifocal or non-contiguous tumor resulting in multiple resection cavities
Evidence of tumor dissemination (ependymal, leptomeningeal)
Tumors that result in a lobectomy or after resection leave an insufficient residual cavity to receive the expected OncoGel volume
Expected communication between the ventricle and resection cavity that cannot be repaired
Involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve or any other cranial nerve
Significantly increased intracranial pressure
Received any type of stereotactic radiosurgery or brachytherapy with the exception of a stereotactic radiosurgery boost as part of the initial radiation therapy
History of seizures refractory to two or more anticonvulsant medications co-administered at therapeutic levels
Impaired organ function as evidenced by clinically significant laboratory parameters including but not limited to the following: Hepatic Status: Bilirubin >2.0 mg/dL; Aspartate transaminase (AST) >2.5 times the normal limit; Alanine aminotransferase (ALT) >2.5 times the normal limit. Hematopoietic Status: Absolute neutrophil count (ANC) <1500mm3; Platelet count <100,000/mm3; Hemoglobin < 10 g/dL. Hemostatic: Prothrombin Time (PT) or INR above normal range; Partial Thromboplastin Time (PTT) above normal range; Bleeding Time outside normal range (if performed by hospital). Renal Status: Serum creatinine >2 mg/dL.
Contraindication to MRI
Receipt any chemotherapeutic agent within 28 days of Study Day 1 or nitrosourea within 6 weeks of Study Day 1
Received any intracerebral investigational agent
Receipt of another investigational drug or device within 28 days of the planned surgery
Known history of allergy to paclitaxel or any other component of OncoGel
Pregnant or lactating
Concurrent life-threatening disease
Any medical condition or other circumstance that, in the opinion of the Investigator, would make the subject unlikely or unable to successfully complete the study, or would interfere with analysis of study results