Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Treating Young Patients With Relapsed or Progressive Cancer
Recruitment status was Active, not recruiting
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.
Brain and Central Nervous System Tumors
Unspecified Childhood Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
- Time to disease progression [ Designated as safety issue: No ]
- Tumor response [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Different radiographic techniques as markers of response [ Designated as safety issue: No ]
- Biological markers as markers of response/angiogenesis [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Estimated Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
- Evaluate the activity of etoposide, cyclophosphamide, thalidomide, celecoxib, and fenofibrate, in terms of prolonging the time to disease progression, in young patients with relapsed or progressive cancer.
- Determine, preliminarily, the biologic activity of this regimen, in terms of tumor response and overall survival, in these patients.
- Determine the toxicity of this regimen in these patients.
- Evaluate different radiographic techniques as markers of tumor response in these patients.
- Evaluate the predictive ability of in vitro correlative studies as markers of tumor response.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type (leukemia/lymphoma vs bone tumors [Ewing's sarcoma, osteosarcoma] vs neuroblastoma vs high-grade glial tumors vs low-grade glial tumors vs ependymomas vs medulloblastoma/primitive neuroectodermal tumor [PNET] vs miscellaneous tumors).
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).
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357500
|United States, Connecticut|
|Connecticut Children's Medical Center|
|Hartford, Connecticut, United States, 06106|
|United States, Florida|
|Miami Children's Hospital|
|Miami, Florida, United States, 33155-4069|
|United States, Illinois|
|Children's Memorial Hospital - Chicago|
|Chicago, Illinois, United States, 60614|
|United States, Maine|
|Maine Medical Center Research Institute|
|Scarborough, Maine, United States, 04074-7205|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|Children's Hospitals and Clinics of Minnesota - Minneapolis|
|Minneapolis, Minnesota, United States, 55404|
|United States, Missouri|
|St. Louis Children's Hospital|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|United States, New York|
|NYU Cancer Institute at New York University Medical Center|
|New York, New York, United States, 10016|
|United States, Rhode Island|
|Hasbro Children's Hospital|
|Providence, Rhode Island, United States, 02903|
|Study Chair:||Mark W. Kieran, MD, PhD||Dana-Farber Cancer Institute|