5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. Etoposide
phosphate, prednisone, vincristine sulfate (Oncovin), cyclophosphamide, and doxorubicin
hydrochloride (hydroxydaunorubicin)(EPOCH): Etoposide, VP-16, NSC-141540; Prednisone,
PRED, NSC-10023; Vincristine, VCR, NSC-67574; Cyclophosphamide, CTX, NSC-26271;
Doxorubicin, DOX, NSC-123127; with Granulocyte Colony-Stimulating Factor (Amgen),
Granulocyte colony-stimulating factor (G-CSF), NSC-614629.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00001337.
Background:
The treatment of the intermediate and aggressive non-Hodgkin's lymphomas in adults and
children commonly induces complete responses in a sizable fraction of the treated
population, and about 2/3 of the complete responders appear to have prolonged
disease-free survival.
The present study assesses the activity and tolerability in previously untreated patients
of a regimen of etoposide phosphate, prednisone, vincristine sulfate (Oncovin),
cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin)(EPOCH) infusional
chemotherapy given intensively with granulocyte colony-stimulating factor (G-CSF)
support.
Objectives:
Primary:
Assess complete response (CR) and progression-free survival (PFS) of dose-adjusted
EPOCH-Rituximab (DA-EPOCH-R) with G-CSF in aggressive B-cell lymphomas.
Eligibility:
Non-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma
(MGZL) and primary mediastinal B cell lymphoma (PMBL).
Patients greater than or equal to 12 years old.
Any Stage for PMBL and MGZL.
No prior systemic chemotherapy.
Human immunodeficiency virus (HIV) negative.
Design:
This study will estimate the complete response rate of a group of previously untreated
patients and the extent to which EPOCH infusional drug delivery accompanied by a
hematopoietic growth factor can increase the dose intensity of treatment.
Patients receive prednisone orally for 5 days, a 96-hour infusion of vincristine,
doxorubicin, and etoposide, and a bolus of cyclophosphamide on day 5.
Cycles are repeated every 21 days for a total of 6-8 cycles.
Patients with cluster of differentiation 20 (CD20) expressing tumors (i.e., mature B-cell
lymphomas) will also receive rituximab, the humanized monoclonal antibody against the
CD20 receptor on day 1 of each cycle.
A total of 348 patients will be enrolled on this protocol.
Lead OrganizationNational Cancer Institute
Principal InvestigatorMark Jason Roschewski