Know Cancer

forgot password

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

Phase 2
Not Enrolling
Hodgkin's Disease, Non Hodgkin's Lymphoma

Thank you

Trial Information

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

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 with PBSC reinfusion and IL-2
following the last cycle of chemotherapy. In all patients, immunological monitoring for
NK/LAK activity, T cell number and function will be performed. The therapy is specifically
targeted for patients who would be candidates for high-dose chemotherapy with stem cell

Inclusion 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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

February 1995

Completion Date:

January 2002

Related Keywords:

  • Hodgkin's Disease
  • Non Hodgkin's Lymphoma
  • IL-2
  • Drug Resistance
  • Continuous Infusion
  • Peripheral Stem Cells
  • MDR
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin



National Cancer Institute (NCI) Bethesda, Maryland  20892