Gliadel Wafers and Temodar in the Treatment of Glioblastoma Multiforme

NCT00574964 | Terminated Phase 2 DMC

• 1 other identifier: 200408035
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine if combining all three treatments of Gliadel wafers, Temozolomide and Radiation therapy at the same time is safe and more effective than one treatment at a time. The study will measure the survival of subjects treated with this combination of drugs.

Conditions

Primary Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Determine the safety and feasibility of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant temozolomide, followed by adjuvant temozolomide, in subjects undergoing initial surgery for newly-diagnosed malignant gliomas.

  Will follow subjects to collect DOD.

Secondary Outcomes (1)

• Determine the progression free survival at 6 months, medial survival, and one year survival rate of this subject population. Determine objective response rate.

  Will follow subject to collect DOD.

Study Arms (1)

1

EXPERIMENTAL

Other: Gliadel Wafer, Temodar and Radiotherapy

Interventions

Gliadel Wafer, Temodar and Radiotherapy OTHER

Given concurrently starting 10-30 days after surgery.

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document.
• Subjects must have findings on neuroimaging studies and clinical evaluation consistent with the diagnosis of a primary brain tumor in order to be offered enrollment in the study. Subsequently, in order to remain on study, they must have histologically or cytologically confirmed primary tumor of the brain. Intra-operative confirmation of histology (i.e. frozen section assessment or equivalent) is required for all subjects. Gliadel wafers will not be implanted without positive intraoperative histopathology consistent with a primary tumor of the brain. The final classification and evaluability determination will be made based on post-operative histological reports showing anaplastic astrocytoma or Glioblastoma multiforme. No central pathology review will be required.
• Newly diagnosed supratentorial primary brain lesion as visualized on enhanced MRI scan (or CT scan with contrast for subjects who cannot undergo MRI) that is appropriate for surgical resection and implantation of Gliadel.
• All eligible subjects will undergo surgical resection. After resection, if there is communication of the resection cavity with the ventricular spaces preventing the use of Gliadel® the subject leaves the study.
• MRI or CT with and without contrast within 30 days of study entry.
• New diagnosis of primary brain tumor is required. No prior therapy, including previous radiotherapy, chemotherapy, or operation is allowed.
• Karnofsky Performance Status greater than or equal to 60.
• Life expectancy of at least 12 weeks.
• Subjects must have normal organ and marrow function as defined below:
• WBC greater than or equal 2,000/mm3
• Absolute neutrophil count greater than or equal to 1,500/mm3
• Platelets greater than or equal to 125,000/mm3
• Total bilirubin less than or equal to 2.0 mg/dl
• AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X upper limit of normal
• PT / PTT within 1.5 X upper limit of normal

You may not qualify if:

• Known hypersensitivity or allergy to BCNU (carmustine) or other components of the Gliadel® wafer such as polifeprosan polymer.
• Known hypersensitivity to temozolomide.
• Subjects may not be receiving any other investigational agents.
• If the surgeon determines that placement of Gliadel wafers is inappropriate, or if the final diagnosis is other than anaplastic astrocytoma or glioblastoma, the subject will leave the study and not be further analyzed.
• Subjects who have had chemotherapy or radiotherapy at any time for this diagnosis.
• A subject will be considered unresectable preoperatively if, in the opinion of the neurosurgeon, the subject is not a candidate for maximal cytoreductive surgery, (i.e., crosses the midline, continuous with the ventricular space). Such subjects will not be eligible for treatment on this protocol.
• Diagnosis of prior central nervous system tumor.
• Diagnosis of systemic cancer requiring treatment within the past five years (except for non-melanotic carcinoma of the skin or carcinoma in situ of the cervix).
• Open communication of the resection cavity with the ventricular system that prevents insertion of Gliadel or tumors that cross the midline.
• Posterior fossa or brain stem tumor.
• Concurrent severe medical illness (e.g., active infection, acute hepatitis, cardiac arrhythmia, unstable angina, congestive heart failure, uncontrolled diabetes mellitus, uncontrolled seizures, pulmonary insufficiency, pulmonary fibrosis, pulmonary embolus, etc) or psychiatric illness, or abnormal laboratory values that preclude surgical candidacy or limits expected survival to less than 12 weeks.
• Pregnant women are excluded from this study because BCNU and/or Temozolomide are pregnancy risk D pharmaceutical agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BCNU and/or Temozolomide, breastfeeding should be discontinued if the mother is treated with either of these agents. These potential risks may also apply to other agents used in this study.
• Subjects with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive subjects receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with BCNU or other agents administered during the study. Appropriate studies will be undertaken in subjects receiving combination anti-retroviral therapy when indicated.

Sponsors & Collaborators

• University of Iowa: lead
• Eisai Inc.: collaborator

Study Sites (1)

Holden Comprehensive Cancer Clinic

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Carmustine; Temozolomide; Radiotherapy

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Timothy Ryken, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 17, 2007
• Study Start: October 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: June 1, 2008
• Last Updated: October 27, 2016

Record last verified: 2010-03

Locations

US (1)