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Phase II Trial of Temodar Plus O6-Benzylguanine (O6-BG) (NSC 637037) in the Treatment of Patients With Temodar-Resistant Malignant Glioma

Phase 2
18 Years
Not Enrolling
Glioblastoma Multiforme, Anaplastic Glioma

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Trial Information

Phase II Trial of Temodar Plus O6-Benzylguanine (O6-BG) (NSC 637037) in the Treatment of Patients With Temodar-Resistant Malignant Glioma

2 separate strata accrued independently of each other: Stratum 1-patients with Glioblastoma
Multiforme (GBM). Stratum 2-patients with Anaplastic Glioma [anaplastic astrocytoma (AA),
anaplastic oligodendroglioma (AO), anaplastic mixed (AA and AO)] .

BG at 120mg/m2 administered intravenously over 1 hour followed immediately by 48-hour
infusion at 30mg/m2/24hrs. Temozolomide 472mg/m2 administered orally, in fasting state,
within 60 minutes of end of the 1-hour administration of BG infusion. Treatment cycles may
be repeated every 28 days following dose of Temodar from previous cycle.

Temodar has been well tolerated by both adults and children with most common toxicity being
mild myelosuppression. Other, less likely, potential toxicities include nausea and vomiting,
constipation, headache, alopecia, rash, burning sensation of skin, esophagitis, pain,
diarrhea, lethargy, hepatotoxicity, anorexia, fatigue and hyperglycemia. Hypersensitivity
reactions have not yet been noted with Temodar. As in the case with many anti-cancer drugs,
Temodar may be carcinogenic. BG toxicities include agitation, lethargy, nausea, vomiting,
rapid heart rate, elevated liver functions, & leukemia; but, not with BG as single agent.
Transient lymphopenia has been seen with BG as single agent.

Inclusion Criteria:

- Patients have recurrent/progressive Malignant Glioma (MG). Stereotactic biopsy at
time of recurrence/progression is only required if radiation-induced necrosis is

- Patients have MG resistant to Temodar, which is defined as > or = to 25 percent
increase in tumor growth on contrast enhanced MRI/CT within 8 weeks of last dose of

- Age > or = to 18 years

- Evidence of measurable enhancing disease on contrast-enhanced MRI, unless medically

- Interval of at least 2 weeks between prior surgical resection/ 4 weeks between prior
radiotherapy/chemotherapy, and enrollment on protocol unless there is unequivocal
evidence of tumor progression. However, patients treated with chemotherapy agents
such as VP-16 who would normally be retreated after shorter intervals may be treated
at usual starting time even if less than 4 weeks from last prior dose of chemotherapy

- Karnofsky performance score > or = to 60 percent

- Hematocrit > 29 percent, absolute neutrophil count (ANC) > 1,500 cells/microliter,
platelets > 100,000 cells/microliter

- Serum creatinine <1.5 mg/dl, Blood Urea Nitrogen (BUN) <25 mg/dl, Serum Glutamic
Oxaloacetic Transaminase (SGOT) & bilirubin <1.5 x upper limit of normal (ULN)

- For patients on corticosteroids, they must have been on stable dose for 1 week prior
to entry, if clinically possible, and dose should not be escalated over entry dose

- Signed informed consent approved by Institutional Review Board (IRB) prior to patient

- If sexually active, patients will take contraceptive measures for duration of

Exclusion criteria:

- Pregnancy

- Co-medication that may interfere with study results

Type of Study:


Study Design:

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

Outcome Measure:

Radiographic evidence of tumor response

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

David A. Reardon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System


United States: Food and Drug Administration

Study ID:




Start Date:

October 2002

Completion Date:

August 2008

Related Keywords:

  • Glioblastoma Multiforme
  • Anaplastic Glioma
  • Temodar
  • Temozolomide
  • O6-BG
  • O6-Benzylguanine
  • NSC 637037
  • Temodar-Resistant Malignant Glioma
  • Brain tumor
  • CNS tumor
  • Cerebral glioblastoma
  • Anaplastic astrocytomas
  • Glioma
  • Glioblastoma
  • Glioma



Duke University Health SystemDurham, North Carolina  27705