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

This study has been terminated.
(Sponsor business decision, not based on safety or efficacy data)
Sponsor:
Information provided by:
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT00479765
First received: May 24, 2007
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.

The purpose of this study is to evaluate the safety and tolerability of OncoGel when placed into the tumor resection cavity in the brain following surgical removal of the tumor. Dose escalation is conducted by gradually increasing the amount of OncoGel placed in the resection cavity in small groups of patients, and watching the patients closely for side effects before moving to the next dose level. The study will also test whether OncoGel helps to prevent or delay the tumor from regrowing.


Condition Intervention Phase
Glioblastoma Multiforme
Brain Neoplasms
Drug: OncoGel (ReGel/Paclitaxel)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Occurence of Dose-limiting Toxicities (DLTs) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    any evidence or sign of a dose-limiting toxicity after administration to determine the maximum tolerated dose (MTD)


Enrollment: 4
Study Start Date: March 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel
Drug: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479765

Locations
United States, Illinois
The University of Chicago Brain Tumor Center
Chicago, Illinois, United States, 60637
United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
BTG International Inc.
Investigators
Principal Investigator: Maciej S Lesniak, MD University of Chicago
  More Information

No publications provided

Responsible Party: Claire Daugherty, Clinical Project Manager, Protherics
ClinicalTrials.gov Identifier: NCT00479765     History of Changes
Other Study ID Numbers: PR016-CLN-pro002, OGL-109
Study First Received: May 24, 2007
Results First Received: April 17, 2014
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by BTG International Inc.:
glioblastoma multiforme
recurrent
Phase 1
Phase 2
Phase I
Phase II
brain
cancer
paclitaxel
intracranial
tumor
local
chemotherapy
brain tumor
brain cancer
glioma
OncoGel

Additional relevant MeSH terms:
Brain Neoplasms
Glioblastoma
Astrocytoma
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014