Clinical trial · Interventional
Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas
- 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: Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide and celecoxib with etoposide and cyclophosphamide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and celecoxib with etoposide and cyclophosphamide in treating patients who have relapsed or refractory malignant 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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | 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 intracranial malignant glioma, including glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified
* Unequivocal evidence of relapsed or refractory disease by MRI or CT scan and/or tumor resection
* Steroid therapy prior to MRI or CT scan must have been at a stable dose for at least 5 days
* Failed prior radiotherapy
* Must have confirmation of true progression rather than radiation necrosis if previously treated with interstitial brachytherapy or stereotactic radiosurgery
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* More than 2 months
Hematopoietic
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin greater than 9 g/dL
* 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
* Creatinine less than 1.5 times upper limit of normal (ULN) OR
* BUN 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
* No peripheral neuropathy grade 2 or greater
* No active infection
* No other serious concurrent medical illness
* No concurrent illness that may obscure toxicity or dangerously alter drug metabolism
* No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* Must participate in the System for Thalidomide Education and Prescribing Safety program
* 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 oral thalidomide or celecoxib for more than 2 months duration
Chemotherapy
* No prior oral etoposide or cyclophosphamide for more than 2 months duration
* Prior standard-dose IV etoposide and cyclophosphamide allowed
Endocrine therapy
* See Disease Characteristics
* Concurrent steroids allowed
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
Surgery
* See Disease Characteristics
* Prior surgery for relapsed or refractory disease allowed
* Recovered from prior surgery
* No concurrent surgery
Other
* No other concurrent investigational agents or treatment
* No other concurrent anticancer therapy
* Concurrent antiseizure medications allowedReferences
Publications (0)
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