Clinical trial · Interventional
Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting
- 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 use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may increase the effectiveness of temozolomide by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide, thalidomide, and celecoxib following radiation therapy in treating patients who have 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 |
| celecoxib | Drug | Celecoxib | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed supratentorial glioblastoma multiforme or gliosarcoma * Completed standard external beam radiotherapy within the past 5 weeks * Stable disease by MRI or CT scan PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * More than 4 months Hematopoietic * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * No history of bleeding disorder Hepatic * Bilirubin less than 1.5 mg/dL * SGPT less than 2.5 times normal * Alkaline phosphatase less than 2.5 times normal Renal * BUN less than 1.5 times upper limit of normal (ULN) OR * Creatinine less than 1.5 times ULN Cardiovascular * No deep vein thrombosis within the past 3 weeks (must be clinically stable) Pulmonary * No pulmonary embolism within the past 3 weeks (must be clinically stable) Other * Must participate in System for Thalidomide Education and Prescribing Safety program * No peripheral neuropathy grade 2 or greater * No active infection * No concurrent illness that may obscure toxicity or dangerously alter drug metabolism * No other serious concurrent illness * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy * No prior thalidomide * No concurrent immunotherapy * No concurrent prophylactic filgrastim (G-CSF) Chemotherapy * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy * Concurrent corticosteroids must be at stable or decreasing dose over the past 7 days Radiotherapy * See Disease Characteristics * No concurrent radiotherapy Surgery * No concurrent surgery Other * No other concurrent anticancer therapy * No other concurrent investigational agents
References
Publications (1)
- RESULTKesari S, Schiff D, Henson JW, Muzikansky A, Gigas DC, Doherty L, Batchelor TT, Longtine JA, Ligon KL, Weaver S, Laforme A, Ramakrishna N, Black PM, Drappatz J, Ciampa A, Folkman J, Kieran M, Wen PY. Phase II study of temozolomide, thalidomide, and celecoxib for newly diagnosed glioblastoma in adults. Neuro Oncol. 2008 Jun;10(3):300-8. doi: 10.1215/15228517-2008-005. Epub 2008 Apr 10. PMID 18403492