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Phase II Trial of Gliadel Plus 06-Benzylguanine for Patients With Recurrent Glioblastoma Multiforme

Phase 2
18 Years
Not Enrolling
Recurrent Adult Brain Tumor

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Trial Information

Phase II Trial of Gliadel Plus 06-Benzylguanine for Patients With Recurrent Glioblastoma Multiforme


- 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.

Inclusion Criteria



- 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.

Type of Study:


Study Design:

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

Outcome Measure:

6-month overall survival

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Jennifer A. Quinn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Food and Drug Administration

Study ID:

Pro00004127 (CDR0000483768)



Start Date:

April 2004

Completion Date:

July 2008

Related Keywords:

  • Recurrent Adult Brain Tumor
  • adult glioblastoma multiforme
  • adult gliosarcoma
  • recurrent adult brain tumor
  • Brain Neoplasms
  • Glioblastoma



Duke Comprehensive Cancer Center Durham, North Carolina  27710