Clinical trial · Interventional
Temozolomide in Treating Patients With Recurrent High-Grade Glioma
Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma
NCT00619112CI-TRIAL-00031458completedPhase 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 high-grade 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 |
|---|---|---|---|
| Recurrent Central Nervous System Neoplasm | Central Nervous System Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide
- description
- single arm trial; Patients treated with temozolomide at a dose of 150mg/m2 daily for seven consecutive days of every other week. One 28-day cycle will include treatment with temozolomide on days 1-7 and days 15-21 with no treatment on days 8-14
- interventionNames
- Drug: temozolomide
Primary outcomes (1)
- measure
- 6 Month Progression-free Survival
- timeFrame
- First day of treatment until progression or until 6 months mark
- description
- Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival
Secondary outcomes (6)
- measure
- Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Patients with radiographically proven recurrent, intracranial malignant glioma will be eligible for this protocol. * All patients must sign an informed consent * Patients must have had external beam radiation; there is no limit to the number of prior chemotherapies used. * Patients must be \> 18 years old, and with a life expectancy \> 8 weeks. * Patients must have a Karnofsky performance status of \> 60. * At the time of registration: Patients must have recovered from the toxic effects of prior therapy: * Patients must have adequate bone marrow function. * Patients must have shown unequivocal radiographic evidence for tumor progression by MRI * Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: They have recovered from the effects of surgery. Residual disease following resection of recurrent intracranial malignant glioma is not mandated for eligibility into the study. * Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 42 days from the completion of radiation therapy to study entry. * Patients with prior therapy that included interstitial brachytherapy, stereotactic radiosurgery, or Gliadel wafers must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or MR spectroscopy or surgical documentation of disease. * Male and female patients with reproductive potential must use an approved contraceptive method Exclusion Criteria * Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy * Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible. * Patients must not have active infection or serious intercurrent medical illness. * Patients must not be pregnant/breast feeding and must agree to practice adequate contraception.
References
Publications (1)
- DERIVEDHan SJ, Rolston JD, Molinaro AM, Clarke JL, Prados MD, Chang SM, Berger MS, DeSilva A, Butowski NA. Phase II trial of 7 days on/7 days off temozolmide for recurrent high-grade glioma. Neuro Oncol. 2014 Sep;16(9):1255-62. doi: 10.1093/neuonc/nou044. Epub 2014 Mar 26. PMID 24670608