Clinical trial · Interventional
Temsirolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase I Study of CCI-779, and Temozolomide in Combination With Radiation Therapy in Glioblastoma Multiforme
NCT00316849CI-TRIAL-00009976completedPhase 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)
This phase I trial is studying the side effects and best dose of temsirolimus when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma multiforme. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temsirolimus together with temozolomide and radiation therapy may kill more tumor cells.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Giant Cell Glioblastoma | Adult Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Glioblastoma | Adult Glioblastoma | ONTOLOGY_EXACT | 0.98 |
| Adult Gliosarcoma | Adult Gliosarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| adjuvant therapy | Procedure | — | UNRESOLVED |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
| temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (temsirolimus, temozolomide, radiation therapy)
- description
- GROUP 1: (temsirolimus with radiation and temozolomide) Patients receive temsirolimus IV over 30 minutes once weekly. Beginning 7-10 days later, patients also receive oral temozolomide daily and undergo concurrent 3-D conformal radiotherapy or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients with stable or responding disease proceed to adjuvant therapy. GROUP 2: (radiation and temozolomide) Patients receive oral temozolomide daily and undergo concurrent 3-D conformal radiotherapy or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients with stable or responding disease proceed to adjuvant therapy. ADJUVANT THERAPY: Beginning 4-6 weeks after the completion of chemoradiotherapy patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: pharmacological study
- Procedure: adjuvant therapy
- Radiation: 3-dimensional conformal radiation therapy
- Radiation: intensity-modulated radiation therapy
- Drug: temsirolimus
- Drug: temozolomide
Primary outcomes (6)
- measure
- Maximally tolerated dose (MTD), determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed glioblastoma multiforme (GBM) * Gliosarcoma and other grade 4 astrocytoma variants (e.g., giant cell glioblastoma) allowed * Newly diagnosed disease * Has undergone surgical resection or biopsy of the tumor at least 1 week but no more than 6 weeks ago * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Platelet count ≥ 100,000/mm\^3 * Total bilirubin ≤ 2.5 times upper limit of normal (ULN) * Cholesterol \< 350 mg/dL * Triglycerides \< 400 mg/dL * AST ≤ 2.5 times ULN * Creatinine ≤ 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of allergy or intolerance to dacarbazine * No ongoing or active infection * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * No gastrointestinal tract disease affecting ability to take oral medication or requiring IV alimentation * No significant traumatic injury within the past 21 days * No active, uncontrolled peptic ulcer disease * No other active cancers requiring therapy * No concurrent combination antiretroviral therapy for HIV-positive patients * Willing and able to comply with antibiotic prophylaxis with either trimethoprim/sulfamethoxazole (daily or 3 times per week) or monthly IV pentamidine combined with daily levofloxacin * No prior chemotherapy for any brain tumor * No prior temozolomide or mTOR inhibitor therapies * No prior cranial radiotherapy * More than 21 days since prior major surgery (excluding neurosurgical biopsy or resection of GBM) * No prior surgical procedures affecting absorption * No concurrent enzyme-inducing anticonvulsants, including any of the following: * Carbamazepine * Phenytoin * Phenobarbital * Primidone * No other concurrent investigational agents * Not receiving warfarin prior to study registration * Concurrent warfarin allowed if patients develop an indication for it while enrolled on the protocol
References
Publications (0)
Data not yet available
No reference posted for this study.