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
- 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
- Evaluate the predictive ability of in vitro correlative studies as markers of tumor
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.
Primary Purpose: Treatment
Time to disease progression
Mark W. Kieran, MD, PhD
Dana-Farber Cancer Institute
United States: Federal Government
|Miami Children's Hospital||Miami, Florida 33155-4069|
|Children's Memorial Hospital - Chicago||Chicago, Illinois 60614|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|St. Louis Children's Hospital||Saint Louis, Missouri 63110|
|NYU Cancer Institute at New York University Medical Center||New York, New York 10016|
|Children's Hospitals and Clinics of Minnesota - Minneapolis||Minneapolis, Minnesota 55404|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|Connecticut Children's Medical Center||Hartford, Connecticut 06106|
|Hasbro Children's Hospital||Providence, Rhode Island 02903|
|Maine Medical Center Research Institute||Scarborough, Maine 04074-7205|