Status:
TERMINATED
O(6)-Benzylguanine and Temozolomide in Treating Patients With Glioblastoma Multiforme That Did Not Respond to Previous Temozolomide and Radiation Therapy
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as O(6)-benzylguanine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from divid...
Detailed Description
OBJECTIVES: * Determine the antitumor activity of O6-benzylguanine and temozolomide in patients with temozolomide-resistant methylguanine methyltransferase-positive or -negative glioblastoma multifor...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme (GBM), including the following:
- Small or large cell GBM
- Gliosarcoma
- Temozolomide-resistant disease, as defined by the following:
- Unequivocal evidence of tumor progression after receiving adjuvant temozolomide therapy for 5 consecutive days every 28 days for ≥ 2 courses
- Must have failed prior radiotherapy
- Progression must be documented by MRI (while on a stable steroid dose for ≥ 5 days) ≥ 12 weeks after completion of radiotherapy
- Must have paraffin-embedded tissue blocks or ≥ 4 unstained paraffin-embedded microscope slides available from diagnosis
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy \> 8 weeks
- White blood cell (WBC) ≥ 3,000/mm(³)
- Absolute neutrophil count ≥ 1,500/mm(³)
- Platelet count ≥ 100,000/mm(³)
- Hemoglobin ≥ 10 g/dL (transfusion allowed)
- Aspartate aminotransaminase (AST) \< 2 times upper limit of normal (ULN)
- Bilirubin \< 2 times ULN
- Creatinine \< 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- No significant medical illness that, in the opinion of the investigator, would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant active cardiac, hepatic, renal, or psychiatric disease
- No other known active malignancy except for nonmelanoma skin cancer or carcinoma in situ of the cervix
- No active infection requiring intravenous (IV) antibiotics
- No disease that would obscure toxicity or alter drug metabolism
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior temozolomide
- Prior resection of recurrent or progressive tumor allowed if all the following criteria are met:
- Recovered from prior surgery
- Residual disease after resection of recurrent tumor by computed tomography (CT) scan or magnetic resonance imaging (MRI) (while on a stable steroid dose for ≥ 5 days) ≤ 96 hours OR ≥ 4 weeks after surgery
- At least 12 weeks since prior radiotherapy
- No other prior therapy (i.e., polifeprosan 20 with carmustine implant \[Gliadel wafers\] or nitrosoureas)
- No other concurrent chemotherapy, radiotherapy, immunotherapy, or investigational agents
Exclusion
Key Trial Info
Start Date :
November 13 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00436436
Start Date
November 13 2006
End Date
April 14 2010
Last Update
March 28 2017
Active Locations (2)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
2
NCI - Neuro-Oncology Branch
Bethesda, Maryland, United States, 20892-8200