Clinical trial · Interventional
O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
A Trial of 06-BG and BCNU in Children With CNS Tumors
NCT00003765CI-TRIAL-00009325completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Phase I trial to study the effectiveness of O6-benzylguanine and carmustine in treating children who have refractory CNS tumors. 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.
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 |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| O6-benzylguanine | Drug | O6-Benzylguanine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive O6-benzylguanine IV over 1 hour, then, 1 hour later, carmustine IV is administered over 1 hour. Treatment is repeated every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of carmustine until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose level at which fewer than 2 of 6 patients experience dose limiting toxicity (DLT). If myelosuppression is the DLT, stratum 1 is closed and patients are accrued to stratum 2. If neutropenia is the DLT in stratum 2, patients receive filgrastim (G-CSF) subcutaneously beginning on day 2 and continuing until blood counts recover.
- interventionNames
- Drug: O6-benzylguanine
- Drug: carmustine
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically proven CNS tumor that is refractory to conventional therapy or for which no effective therapy is known * Histological requirement may be waived for brainstem and optic gliomas * Stratum 2: No bone marrow involvement PATIENT CHARACTERISTICS: * Age: 21 and under * Performance status: Karnofsky 50-100% OR Lansky 50-100% * Life expectancy: At least 8 weeks * Absolute neutrophil count at least 1500/mm3 * Platelet count at least 100,000/mm3 (stratum 2: at least 125,000/mm3) * Hemoglobin at least 8 g/dL * Bilirubin less than 1.5 mg/dL * SGOT/SGPT no greater than 2.5 times normal * Creatinine or GFR normal for age * If required, DLCO must be 80% of normal and patient old enough to cooperate for DLCO test * Neurologic deficits must be stable for at least 2 weeks prior to study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study PRIOR CONCURRENT THERAPY: * At least 7 days since prior biologic therapy or immunotherapy and recovered * At least 6 months since prior bone marrow transplant (stratum 1 only) * At least 7 days since prior growth factors * No concurrent filgrastim (G-CSF) prophylaxis * Stratum 2: No prior bone marrow transplantation * At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered * Stratum 2: No greater than 2 prior chemotherapy regimens * No prior nitrosourea therapy * If receiving dexamethasone, must be on stable or decreasing dose for at least 2 weeks prior to study * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 6 months since prior substantial bone marrow radiation, total body irradiation, hemipelvic radiotherapy, or total abdominal/pelvic/chest or mantle/Y ports radiotherapy * Recovered from prior radiotherapy * Stratum 2: No prior central axis radiation * No other concurrent anticancer or investigational agents
References
Publications (1)
- RESULTAdams DM, Zhou T, Berg SL, Bernstein M, Neville K, Blaney SM; Children's Oncology Group. Phase 1 trial of O6-benzylguanine and BCNU in children with CNS tumors: a Children's Oncology Group study. Pediatr Blood Cancer. 2008 Mar;50(3):549-53. doi: 10.1002/pbc.21362. PMID 17941066