Phase 2
Completed N=101
Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Relapsed or Progressive Cancer
Source: ClinicalTrials.gov NCT00357500 ↗Enrolled (actual)
101
Serious AEs
76.3%
Results posted
Sep 2014
Primary outcomePrimary: Therapy Completion Rate — .25 proportion of patients
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapy Completion Rate |
.25 | — |
| SECONDARY 27-Week Progression-Free Survival |
0.31 | — |
| SECONDARY 27-Week Overall Survival |
0.61 | — |
| SECONDARY Best Response |
1; 12; 36; 47; 1 | — |
Eligibility Criteria
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 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 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 allowed
Data sourced from ClinicalTrials.gov (NCT00357500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.