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Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00362921
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : July 10, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and O6-benzylguanine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving Gliadel wafer together with O6-benzylguanine works in treating patients with recurrent glioblastoma multiforme.

Condition or disease Intervention/treatment Phase
Recurrent Adult Brain Tumor Drug: Gliadel wafers in combination with O6-benzylguanine Phase 2

Detailed Description:


  • Define the activity of Gliadel® wafers in combination with a 5-day infusion of O6-benzylguanine in patients with recurrent glioblastoma multiforme.
  • Define the toxicity of Gliadel® wafers in combination with 5-day infusion of O6-benzylguanine in patients with recurrent glioblastoma multiforme.

OUTLINE: This is an open-label study.

Patients undergo surgical resection of tumor followed by placement of Gliadel® wafers . Within 6 hours after completion of surgery, patients receive a 1 hour high dose infusion of O6-benzylguanine followed by a lower dose continuous infusion for 5 days. Every 48 hours a repeat infusion of the high dose over 1 hour will be administered for a total of 3 doses.

After completion of study treatment, patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 50 patients should be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Gliadel Plus 06-Benzylguanine for Patients With Recurrent Glioblastoma Multiforme
Study Start Date : April 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: Gliadel wafers in combination with O6-benzylguanine Drug: Gliadel wafers in combination with O6-benzylguanine
Other Name: Gliadel wafer (carmustine)

Primary Outcome Measures :
  1. 6-month overall survival [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. One year overall survival [ Time Frame: 1 year ]
  2. 2 year overall survival [ Time Frame: 2 years ]
  3. Median overall survival [ Time Frame: 2 years ]
  4. Toxicity prevalence [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No



  • Histologically confirmed recurrent glioblastoma multiforme (including gliosarcoma) which can be confirmed, if not earlier, by intraoperative pathological diagnosis on frozen section
  • Evidence of a unilateral, single focus of measurable Central Nervous System (CNS) neoplasm on contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) scan that is supratentorial and measures ≥ 1.0 cm in diameter


  • Greater than or equal to 18 years old
  • Life expectancy of greater than 12 weeks
  • Karnofsky performance status greater than or equal to 60%
  • Absolute neutrophil count ≥ 1,000/millimeters (mm)³
  • Platelet count ≥ 100,000/mm³
  • Total Serum Bilirubin < 2 times upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) < 3 times ULN
  • Blood urea nitrogen (BUN) < 1.5 times ULN
  • Creatinine < 1.5 times ULN
  • Negative pregnancy test
  • Recovered from any effects of major surgery
  • Patients or legal guardian must give written, informed consent.


  • At least 2 weeks since prior surgical resection (if conducted) and recovered, unless there is unequivocal evidence of tumor progression
  • At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas), unless there is unequivocal evidence of tumor progression.. However, patients treated with chemotherapeutic agents such as etoposide who would normally be retreated after shorter intervals (eg, 21 days on, 7 days off schedule) may be treated at the usual starting time even if less than 4 weeks from the last prior dose of chemotherapy.


  • Patients who have not recovered from surgery
  • Patients who are not neurologically stable for 2 weeks prior to study entry
  • Patients who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics
  • Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)
  • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
  • Known HIV positivity or AIDS-related illness
  • Pregnant or nursing women
  • Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
  • Men who are not advised to use an effective method of contraception
  • Patients taking immuno-suppressive agents other than prescribed corticosteroids
  • Patients who have had prior treatment with Gliadel Wafers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00362921

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United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
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Study Chair: Jennifer A. Quinn, MD Duke Cancer Institute
Publications of Results:
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Responsible Party: Duke University Identifier: NCT00362921    
Other Study ID Numbers: Pro00004127
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: February 2013
Keywords provided by Duke University:
adult glioblastoma multiforme
adult gliosarcoma
recurrent adult brain tumor
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors