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A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma

Phase 1/Phase 2
18 Years
70 Years
Not Enrolling
Glioblastoma Multiforme, Brain Neoplasms

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Trial Information

A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma

This study is for patients with recurrent glioblastoma multiforme. Because most recurrences
are in the area of the original resection, local delivery of a chemotherapeutic agent may
prevent or delay additional recurrences. Paclitaxel has demonstrated activity against 9L
glioma tumor lines, but has poor central nervous system penetration after intravenous
administration. OncoGel is a new formulation of paclitaxel in a bioerodible gel that can be
administered directly to the brain, thereby bypassing the blood-brain barrier.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

occurence of dose-limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Maciej S Lesniak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

November 2010

Related Keywords:

  • Glioblastoma Multiforme
  • Brain Neoplasms
  • glioblastoma multiforme
  • recurrent
  • Phase 1
  • Phase 2
  • Phase I
  • Phase II
  • brain
  • cancer
  • paclitaxel
  • intracranial
  • tumor
  • local
  • chemotherapy
  • brain tumor
  • brain cancer
  • glioma
  • OncoGel
  • Brain Neoplasms
  • Neoplasms
  • Glioblastoma
  • Glioma



University of Rochester Medical Center Rochester, New York  14642
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
The Johns Hopkins University Baltimore, Maryland  21287
University of North Carolina at Chapel Hill Chapel Hill, North Carolina  27599
The University of Chicago Brain Tumor Center Chicago, Illinois  60637