Clinical trial · Interventional
Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM
Phase I Trial of a 5-day Regimen of Temodar Plus O6-Benzylguanine (O6-BG) in the Treatment of Patients With Recurrent / Progressive Glioblastoma Multiforme
- 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)
Primary objectives To determine maxi tolerated dose of Temodar® in combo w O6-benzylguanine administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize toxicity associated w Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM To determine Neulasta®-supported MTD defined as the MTD of Temodar® in combo with O6-BG administered for 5 days while receiving Neulasta® once per treatment cycle between days 7 \& 14 in pts w progressive/recurrent GBM To obtain preliminary response rates of Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliosarcoma | Gliosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temodar and O6-Benzylguanine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- description
- Schedule 1
- interventionNames
- Drug: Temodar and O6-Benzylguanine
- type
- EXPERIMENTAL
- label
- 2
- description
- Schedule 2
- interventionNames
- Drug: Temodar and O6-Benzylguanine
- type
- EXPERIMENTAL
- label
- 3
- description
- Schedule 2, Neulasta-supported
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pts have histologically proven supratentorial GBM * Pts have recurrent/progressive MG. If pt received stereotactic radiosurgery / brachytherapy as part of their prior therapy, then histologic confirmation of recurrence/metabolic imaging consistent w recurrent tumor is recommended but not mandated * There must be measurable disease on contrast-enhanced magnetic resonance imaging study / CT scan performed \<2wks of study drug administration * Interval of \>12 wks between completion of XRT \& enrollment on protocol * Interval of \>4 wks between prior chemo \& enrollment on protocol unless there is unequivocal evidence of tumor progression * Interval of \>2 wks between prior surgical resection \& enrollment on protocol unless there is unequivocal evidence of tumor progression * Age \>18 yrs * KPS \>70 percent * Following baseline study will be required \<1wk of study drug administration: serum creatinine \< 1.5 x ULN \& Hematologic Status * Following baseline studies will be required \<1wk of study drug administration: absolute neutrophil count \>2000 cells/microliter; platelet count \>125,000 cells/microliter * Following baseline studies will be required \<1 wk of study drug administration: serum SGOT \& total bilirubin \< 2.5 x ULN * Signed informed consent, approved by IRB, will be obtained prior to initiating treatment * Pts w Reproductive Potential: Pts must agree to practice effective birth control measures while on study \& for 2 months after completing therapy Exclusion Criteria: * Pregnant/breast feeding women/ women/men w reproductive potential not practicing adequate contraception. Therapy may be associated w potential toxicity to fetus/child that exceeds mini risks necessary to meet health needs of mother * Prior treatment w O6-BG + Temozolomide in combo * Active infection requiring intravenous antibiotics * Known diagnosis of HIV infection * Pts w history of another primary malignancy that is currently clinically significant/currently requires active intervention * Pts unwilling/unable to comply w protocol due to serious medical/psychiatric condition * Pts who have received investigational drugs \<2 wks prior to start on study drug/have not recovered from side effects of such therapy.
References
Publications (0)
Data not yet available