Clinical trial · Interventional
Ph. I Temozolomide + O6-BG + Irinotecan in Treatment of Pts w Recurrent / Progressive Cerebral Anaplastic Gliomas
Phase I Trail of Temodar Plus O6-Benzylguanine (O6-BG) (NSC 637037) Plus Irinotecan (CPT-11) (NSC 616348) in the Treatment of Patients With Recurrent / Progressive Cerebral Anaplastic Gliomas
NCT00612638CI-TRIAL-00010838completedPhase 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)
Objectives: To determine maximum tolerated dose of CPT-11 when administered following Temodar plus O6-benzylguanine To characterize any toxicity associated w combo of CPT-11 + Temodar plus O6-BG To observe pts for clinical antitumor response when treated w combo of CPT-11 + Temodar + O6-BG
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, O6-BG, and Irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Pts receiving Dilantin, Tegretol or Phenobarbital
- interventionNames
- Drug: Temodar, O6-BG, and Irinotecan
- type
- EXPERIMENTAL
- label
- 2
- description
- Pts on anti-convulsants other than Dilantin, Tegretol / Phenobarbital / pts not on any anti-convulsants
- interventionNames
- Drug: Temodar, O6-BG, and Irinotecan
Primary outcomes (1)
- measure
- Incidence of toxicities
- timeFrame
- 6 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pts have histologically confirmed diagnosis of recurrent primary malignant glioma * Age \>18yrs * Evidence of measurable recurrent/residual primary CNS neoplasm on contrast-enhanced MRI, unless medically contraindicated * An interval of \>2 wks between prior surgical resection/6 wks between prior XRT/chemo, \& enrollment on protocol, unless there is unequivocal evidence of tumor progression after surgery, XRT/chemo * KPS\>60 percent * Adequate hematologic, renal \& liver function as demonstrated by lab values performed within 14 days, inclusive, prior to administration of chemo: * ANC \>1500/mm3 * Platelet count \> 00,000/mm3 * Hemoglobin \> 10gm/dL * BUN \& serum creatinine \<1.5 x ULN * Total serum bilirubin \<1.5 x ULN * SGOT \& SGPT \< 2.5 x ULN * Alkaline phosphatase of\< 2 x ULN * Pts must have recovered from any effects of major surgery.= * Pts must have life expectancy of \>12wks * Pts/legal guardian must give written, informed consent Exclusion Criteria: * Pts requiring immediate XRT * Pts have not recovered from surgery * Pts are not neurologically stable for 2wks prior to study entry * Pts are poor medical risks because of non-malignant systemic disease as well as those w acute infection treated w intravenous antibiotics * Frequent vomiting/medical condition that could interfere w oral medication intake * Previous active malignancy treated in past year except for localized in-situ carcinomas \& basal/squamous cell carcinoma of skin * Known HIV positivity/AIDS-related illness * Pregnant/nursing women * Women of childbearing potential who are not using effective method of contraception. Women of childbearing potential must have negative serum pregnancy test 24 hrs prior to administration of study drug \& be practicing medically approved contraceptive precautions * Men who are not advised to use effective method of contraception * Prior failure of CPT-11 * Pts taking immuno-suppressive agents other than prescribed corticosteroids
References
Publications (0)
Data not yet available
No reference posted for this study.