Clinical trial · Interventional
O(6)-Benzylguanine and Temozolomide in Treating Patients With Glioblastoma Multiforme That Did Not Respond to Previous Temozolomide and Radiation Therapy
A Phase 2 Study of O-Benzylguanine (O-BG) and Temozolomide in Patients With Glioblastoma Progressing at Least 3 Months After Completion of Primary Treatment With Radiation Therapy and Temozolomide
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed to accrual after the company chose to stop development of the drug.
Summary
Brief summary (as posted)
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 dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving O(6)-benzylguanine together with temozolomide works in treating patients with glioblastoma multiforme that did not respond to previous temozolomide and radiation therapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| O6-benzylguanine | Drug | O6-Benzylguanine | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- O6-benzylguanine & Temozolomide in Glioblastoma
- description
- Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: O6-benzylguanine
- Drug: temozolomide
Primary outcomes (1)
- measure
- Confirmed Best Objective Tumor Response Rate (Complete or Partial Response) in Patients With Methylguanine Methyltransferase (MGMT)-Positive Tumors as Assessed by Immunohistochemistry (IHC)
- timeFrame
- 2-4 weeks
- description
- The date of response will be the date the response is first radiographically documented following initiation of therapy (typically, the date of the actual imaging modality). Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
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