Clinical trial · Interventional
Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and O6-benzylguanine in treating patients who have newly diagnosed, recurrent, or progressive anaplastic glioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| O6-benzylguanine | Drug | O6-Benzylguanine | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
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
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:
* Not specifiedReferences
Publications (2)
- RESULTQuinn JA, Jiang SX, Reardon DA, Desjardins A, Vredenburgh JJ, Rich JN, Gururangan S, Friedman AH, Bigner DD, Sampson JH, McLendon RE, Herndon JE Jr, Walker A, Friedman HS. Phase I trial of temozolomide plus O6-benzylguanine 5-day regimen with recurrent malignant glioma. Neuro Oncol. 2009 Oct;11(5):556-61. doi: 10.1215/15228517-2009-007. Epub 2009 Mar 16. PMID 19289491
- RESULTQuinn JA, Desjardins A, Weingart J, Brem H, Dolan ME, Delaney SM, Vredenburgh J, Rich J, Friedman AH, Reardon DA, Sampson JH, Pegg AE, Moschel RC, Birch R, McLendon RE, Provenzale JM, Gururangan S, Dancey JE, Maxwell J, Tourt-Uhlig S, Herndon JE 2nd, Bigner DD, Friedman HS. Phase I trial of temozolomide plus O6-benzylguanine for patients with recurrent or progressive malignant glioma. J Clin Oncol. 2005 Oct 1;23(28):7178-87. doi: 10.1200/JCO.2005.06.502. PMID 16192602