Clinical trial · Interventional
Temozolomide in Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: Single-arm, Phase II Trial
The Efficacy and Safety of Temozolomide in Patients With Relapsed or Advanced Anaplastic Oligodendroglioma and Oligoastrocytoma: a Multicenter, Single-arm, Phase II Trial
NCT01847235CI-TRIAL-00021915completedPhase 2ClinicalTrials.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)
The purpose of this study is to determine the efficacy and safety of temozolomide in patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.
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 |
|---|---|---|---|
| Anaplastic Oligoastrocytoma | Anaplastic Oligoastrocytoma | CURATED_BROADER | 0.80 |
| Anaplastic Oligodendroglioma | Anaplastic Oligodendroglioma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide
- description
- Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days
- interventionNames
- Drug: Temozolomide
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- 6 month
- description
- PFS will be examined with Kaplan-Meier method.
Secondary outcomes (4)
- measure
- Objective response rate (ORR)
- timeFrame
- 1 year
- description
- ORR will be evaluated through the frequency analysis with 95% confidence interval.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven anaplastic oligodendroglioma or oligoastrocytoma * Progressed or relapsed after surgery or radiation therapy * Female or male aged 20 years or over * At least 1 measurable mass lesion * ECOG performance status 0-3 * Adequate organ function * absolute neutrophil count \> 1,500/μL * platelet count \> 75,000/μL * hemoglobin greater than 9 g/dL or 900g/L * serum creatinine less than 1.5 times the upper limit of laboratory normal * total serum bilirubin less than 1.5 times the upper limit of laboratory normal * AST or ALT less than three times the upper limit of laboratory normal Exclusion Criteria: * Prior course of temozolomide * Combined glioblastoma * Pregnant woman
References
Publications (8)
- BACKGROUNDStupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330. PMID 15758009
- BACKGROUNDPerry JR, Rizek P, Cashman R, Morrison M, Morrison T. Temozolomide rechallenge in recurrent malignant glioma by using a continuous temozolomide schedule: the "rescue" approach. Cancer. 2008 Oct 15;113(8):2152-7. doi: 10.1002/cncr.23813. PMID 18756530
- BACKGROUNDPerry JR, Belanger K, Mason WP, Fulton D, Kavan P, Easaw J, Shields C, Kirby S, Macdonald DR, Eisenstat DD, Thiessen B, Forsyth P, Pouliot JF. Phase II trial of continuous dose-intense temozolomide in recurrent malignant glioma: RESCUE study. J Clin Oncol. 2010 Apr 20;28(12):2051-7. doi: 10.1200/JCO.2009.26.5520. Epub 2010 Mar 22. PMID 20308655
- BACKGROUNDYung WK, Prados MD, Yaya-Tur R, Rosenfeld SS, Brada M, Friedman HS, Albright R, Olson J, Chang SM, O'Neill AM, Friedman AH, Bruner J, Yue N, Dugan M, Zaknoen S, Levin VA. Multicenter phase II trial of temozolomide in patients with anaplastic astrocytoma or anaplastic oligoastrocytoma at first relapse. Temodal Brain Tumor Group. J Clin Oncol. 1999 Sep;17(9):2762-71. doi: 10.1200/JCO.1999.17.9.2762. PMID 10561351
- BACKGROUNDCairncross JG, Ueki K, Zlatescu MC, Lisle DK, Finkelstein DM, Hammond RR, Silver JS, Stark PC, Macdonald DR, Ino Y, Ramsay DA, Louis DN. Specific genetic predictors of chemotherapeutic response and survival in patients with anaplastic oligodendrogliomas. J Natl Cancer Inst. 1998 Oct 7;90(19):1473-9. doi: 10.1093/jnci/90.19.1473. PMID 9776413
- BACKGROUNDVan den Bent MJ, Reni M, Gatta G, Vecht C. Oligodendroglioma. Crit Rev Oncol Hematol. 2008 Jun;66(3):262-72. doi: 10.1016/j.critrevonc.2007.11.007. Epub 2008 Feb 12.