Clinical trial · Interventional
Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme
NCT00099125CI-TRIAL-00013552completedPhase 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)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well radiation therapy, temozolomide, and irinotecan work in treating patients with newly diagnosed glioblastoma multiforme.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RT with chemotherapy + post-radiation chemotherapy
- description
- Radiation therapy (RT) with concurrent chemotherapy + post-radiation chemotherapy
- interventionNames
- Drug: irinotecan hydrochloride
- Drug: temozolomide
- Procedure: adjuvant therapy
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
Secondary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- From randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme by surgical biopsy or excision * No gliomas graded less than glioblastoma multiforme * No recurrent malignant gliomas * No tumor foci below the tentorium or beyond the cranial vault * Study therapy must begin ≤ 5 weeks after surgery PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * At least 8 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL\* * Hematocrit ≥ 30%\* NOTE: \*Transfusion allowed Hepatic * Bilirubin ≤ 0.5 mg/dL * ALT or AST ≤ 2 times upper limit of normal Renal * Creatinine ≤ 1.5 mg/dL * BUN ≤ 25 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-barrier contraception during and for 2 months after study participation * No AIDS * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder * No other major medical illness or psychiatric impairment that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent sargramostim (GM-CSF) Chemotherapy * No other concurrent chemotherapy Endocrine therapy * Concurrent steroid therapy allowed provided patient is on a stable or decreasing dose for at least 2 weeks before study entry Radiotherapy * No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields * Prior radiotherapy for stage T1 glottic cancer allowed Surgery * See Disease Characteristics * Recovered from prior surgery Other * No enzyme-inducing antiepileptic drugs within 14 days before the initiation of irinotecan * Concurrent non-enzyme-inducing antiepileptic drugs allowed
References
Publications (1)
- RESULTLieberman FS, Tsien C, Berkey B, et al.: Phase II trial of concomitant low dose temozolomide with external beam radiation (EBRT) followed by 12 months of temozolomide and irinotecan for newly diagnosed glioblastoma (GBM): preliminary results of RTOG 04-20. [Abstract] J Clin Oncol 24 (Suppl 18): A-1510, 2006.