Clinical trial · Interventional
Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Relapsed or Progressive Cancer
Anti-Angiogenic Chemotherapy: A Phase II Trial of the Oral 5-Drug Regimen (Thalidomide, Celecoxib, Fenofibrate, Etoposide and Cyclophosphamide) in Patients With Relapsed or Progressive Cancer
NCT00357500CI-TRIAL-00015743completedPhase 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 etoposide and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide, celecoxib, and fenofibrate may stop the growth of cancer cells by blocking blood flow to the cancer. Celecoxib also may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with thalidomide, celecoxib, and fenofibrate may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving etoposide and cyclophosphamide together with thalidomide, celecoxib, and fenofibrate works in treating young patients with relapsed or progressive cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Tumor, Pediatric | Childhood Central Nervous System Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| fenofibrate | Drug | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5-drug metronomic antiangiogenic regimen
- description
- Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
- interventionNames
- Drug: celecoxib
- Drug: cyclophosphamide
- Drug: etoposide
- Drug: fenofibrate
- Drug: thalidomide
Primary outcomes (1)
- measure
- Therapy Completion Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed cancer (at diagnosis or relapse), including any of the following:
* Leukemia and/or lymphoma (closed to accrual)
* Bone tumor (e.g., Ewing's sarcoma or osteosarcoma) (closed to accrual)
* Neuroblastoma (closed to accrual)
* High-grade glial tumor
* Low-grade glial tumor
* Ependymoma
* Medulloblastoma and/or primitive neuroectodermal tumor (PNET)
* Miscellaneous tumor (closed to accrual)
* Brain stem glioma, defined as intrinsic tumors of the pons causing diffuse enlargement
* Brain stem glioma that progressed after radiotherapy does not require histological confirmation
* Duration of symptoms at the time of diagnosis must be \< 3 months
* Symptoms should consist of cranial nerve deficits, ataxia, and/or long tract signs
* Relapsed or progressive poor prognosis disease for which no available curative therapy exists
PATIENT CHARACTERISTICS:
* Karnofsky performance status 50-100% OR Lansky play scale 50-100% (for infants)
* Life expectancy \> 2 months
* Platelet count \> 75,000/mm\^3 (transfusion independent)
* Absolute neutrophil count \> 1,000/mm\^3 (in patients without bone marrow disease)
* Hemoglobin ≥ 9.0 g/dL
* Creatinine \< 1.5 mg/dL OR creatinine clearance or glomerular filtration rate ≥ 70 mL/min
* Bilirubin ≤ 1.5 mg/dL
* SGPT ≤ 3 times normal
* SGOT ≤ 3 times normal (4 times normal for patients on ranitidine hydrochloride)
* Alkaline phosphatase ≤ 3 times normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method contraception during and for 2 months after completion of study treatment
* Must be willing to participate in the Celgene STEPS® program
* Recent thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism) allowed if patient is clinically stable and the thromboembolic event occurred \> 3 weeks prior to study entry
* No active infection
* No active uncontrolled cardiac, hepatic, renal, or psychiatric disease ≥ grade 3
* No known allergies to sulfonamides
* No concurrent illness that would obscure toxicity or dangerously alter drug metabolism
* No other serious medical illness
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from prior therapy
* Prior chemotherapy and/or radiotherapy allowed
* Prior celecoxib allowed
* Prior standard-dose IV etoposide and cyclophosphamide administered in 3-week courses allowed
* No prior oral therapy with etoposide, thalidomide, cyclophosphamide, or fenofibrate for \> 2 months in duration
* No other concurrent investigational agents
* No other concurrent nonsteroidal anti-inflammatory drugs
* Concurrent steroids and/or antiseizure medications allowedReferences
Publications (1)
- BACKGROUNDRobison NJ, Campigotto F, Chi SN, Manley PE, Turner CD, Zimmerman MA, Chordas CA, Werger AM, Allen JC, Goldman S, Rubin JB, Isakoff MS, Pan WJ, Khatib ZA, Comito MA, Bendel AE, Pietrantonio JB, Kondrat L, Hubbs SM, Neuberg DS, Kieran MW. A phase II trial of a multi-agent oral antiangiogenic (metronomic) regimen in children with recurrent or progressive cancer. Pediatr Blood Cancer. 2014 Apr;61(4):636-42. doi: 10.1002/pbc.24794. Epub 2013 Oct 4. PMID 24123865