Overview

Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma

Status:
Completed
Trial end date:
2008-08-01
Target enrollment:
0
Participant gender:
All
Summary
Objectives: To define role of O6-Benzylguanine (BG) in restoring Temodar (temozolomide) sensitivity in patients with Temodar-resistant malignant glioma. To further define toxicity of combo therapy using Temodar + BG.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborators:
Keryx / AOI Pharmaceuticals, Inc.
National Institutes of Health (NIH)
Treatments:
Dacarbazine
O(6)-benzylguanine
Temozolomide
Criteria
Inclusion Criteria:

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

- 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
Temodar

- Age > or = to 18 years

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

- 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
level

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

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

Exclusion criteria:

- Pregnancy

- Co-medication that may interfere with study results