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Phase I Study of Temozolomide and O6-Benzylguanine in Patients With Newly Diagnosed or Recurrent or Progressive Cerebral Anaplastic Glioma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Trial Contact Information Registry Information
Alternate Title
Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase I | Treatment | Closed | 18 and over | DUMC-1388-02-8R2 DUMC-1388-00-8, NCI-490, DUMC-1388-01-8R1, NCT00006474, 490 |
Objectives - Determine the dose of O6-benzylguanine (O6-BG) effective in producing complete suppression of tumor O6-alkylguanine-DNA alkyltransferase activity in patients with newly diagnosed (closed to accrual 12/19/2000) or recurrent or progressive cerebral anaplastic glioma.
- Determine the maximum tolerated dose of temozolomide administered after O6-BG in these patients.
- Determine the toxicity of this regimen in these patients.
- Determine the anti-tumor response in patients treated with this regimen.
Entry Criteria Disease Characteristics:
- Part I:
- Histologically confirmed, newly diagnosed glioblastoma multiforme or anaplastic
astrocytoma (closed to accrual 12/19/2000)
- Parts I and II:
- Histologically confirmed astrocytic, oligodendroglial, or mixed glial tumor
- Grade III or higher
- Recurrent or progressive after radiotherapy
- Evaluable residual disease by contrast-enhanced MRI or CT scan
Prior/Concurrent Therapy:
Biologic therapy: - At least 6 weeks since prior biologic therapy and
recovered
Chemotherapy: - At least 2 weeks since prior chemotherapy (including but not
limited to topotecan) and recovered
- Patients in trials with one of the following treatment
combinations are allowed to enroll 6 weeks after receiving carmustine
(BCNU):
- BCNU on day 1
- BCNU on day 1 and topotecan on days 1, 8, 15, 22, 29, and
36
- BCNU on day 1 and irinotecan on days 1, 8, 15, and
22
Endocrine therapy: - Patients on corticosteroids must be on a stable dose for at
least 2 weeks before study
- At least 6 weeks since other prior endocrine therapy and
recovered
Radiotherapy: - See Disease Characteristics
- At least 6 weeks since prior radiotherapy and
recovered
Surgery: Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic: - SGOT no greater than 2.5 times upper limit of normal
- Bilirubin normal
Renal: - Creatinine no greater than 1.5 mg/dL
OR - Creatinine clearance greater than 60 mL/min
- BUN no greater than 25 mg/dL
Other: - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and
for 2 months after study
Expected Enrollment Approximately 20-30 patients (with 14 patients participating in Part II) will be accrued for this study. Outline This is a dose-escalation, multicenter study. Published ResultsQuinn JA, Desjardins A, Weingart J, et al.: Phase I trial of temozolomide plus O6-benzylguanine for patients with recurrent or progressive malignant glioma. J Clin Oncol 23 (28): 7178-87, 2005.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations Duke Comprehensive Cancer Center | | | Henry Friedman, MD, Protocol chair | | | |
Registry Information | | Official Title | | Phase I Trial of Temodar Plus O6-Benzylguanine (O6-BG) (NSC 637037) in the Treatment of Patients with Newly Diagnosed (Part 1) or Recurrent/Progressive (Parts 1 and 2) Cerebral Anaplastic Gliomas | | Trial Start Date | | 2001-03-02 | | Registered in ClinicalTrials.gov | | NCT00006474 | | Date Submitted to PDQ | | 2000-09-26 | | Information Last Verified | | 2003-05-06 | | NCI Grant/Contract Number | | P30-CA14236 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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