A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

Keywords

ClinConnect Summary

This is a randomized study of combination chemotherapy (EPOCH II) versus EPOCH II and immunotherapy with peripheral blood stem cells (PBSC) and IL-2 in patients with relapsed Hodgkin's and non-Hodgkin's lymphomas, and untreated patients with low-grade non-Hodgkin's lymphomas. The chemotherapy entails the administration of multiple cycles of infusional doxorubicin, etoposide and vincristine chemotherapy (total of 3), alternating with cycles of high-dose cyclophosphamide (3 cycles). Patients will be randomized, on a 2:1 basis, to either receive only chemotherapy or to undergo a PBSC harvest w...

Gender

ALL

Eligibility criteria

• • Patients must be between 18 and 70 years old.
• • All stages of patients with low-, intermediate- or high-grade non-Hodgkin's lymphomas, or Hodgkin's disease who have disease following standard chemotherapy.
• • Stage II-IV patients with previously untreated low-grade lymphoma or untreated low-grade with progression.
• • Patients must have received less than or equal to 2 prior combination chemotherapy regimens, no combination chemotherapy refractory disease, no high-dose chemotherapy with stem cell rescue, and may not have CNS involvement by lymphoma.
• • Pathology slides must be reviewed and a diagnosis of lymphoma confirmed by the Hematopathology Section, Laboratory of Pathology, NCI.
• • No patients with a history of coronary artery disease with angina pectoris and/or an ejection fraction less than 42 percent.
• • Serum creatinine clearance greater than 50 cc/min, bilirubin less than 2.5 u and AST/ALT less than 2x normal, absolute neutrophil count greater than 1000/mm(3) and platelet count greater than or equal to 100,000/mm(3) unless due to respective organ involvement by tumor.
• • Patients must have an ECOG performance status less than or equal to 2.
• • Patients must be HIV negative.
• • Pregnant women will be excluded.
• • Patients must be able to give informed consent.
• • Patients who, in the opinion of the principal investigator, are poor psychiatric or medical risks because of non-malignant systemic disease will be excluded.
• • A completed eligibility form.