Clinical trial · Interventional
Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma
NCT00498927CI-TRIAL-00021174completedPhase 2Results postedClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent glioblastoma multiforme or other malignant 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide
- description
- Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
- interventionNames
- Drug: temozolomide
- Genetic: protein expression analysis
- Genetic: reverse transcriptase-polymerase chain reaction
- Other: diagnostic laboratory biomarker analysis
- Other: immunoenzyme technique
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) Rate at 6 Months
- timeFrame
- at 6 months
- description
- Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Pathologically diagnosed glioblastoma multiforme or other malignant glioma * Recurrent disease * Must have received prior temozolomide PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * SGOT ≤ 2.5 times upper limit of normal (ULN) * Creatinine ≤ 2 times ULN * Bilirubin ≤ 2 times ULN * No other active malignancy except for cervical carcinoma in situ or basal cell carcinoma of the skin * No serious medical or psychiatric illness that, in the opinion of the investigator, would preclude study treatment * No medical condition that precludes swallowing pills * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy
References
Publications (1)
- DERIVEDOmuro A, Chan TA, Abrey LE, Khasraw M, Reiner AS, Kaley TJ, Deangelis LM, Lassman AB, Nolan CP, Gavrilovic IT, Hormigo A, Salvant C, Heguy A, Kaufman A, Huse JT, Panageas KS, Hottinger AF, Mellinghoff I. Phase II trial of continuous low-dose temozolomide for patients with recurrent malignant glioma. Neuro Oncol. 2013 Feb;15(2):242-50. doi: 10.1093/neuonc/nos295. Epub 2012 Dec 14. PMID 23243055