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A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas
This study has been completed.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001430
  Purpose

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 support.


Condition Intervention Phase
Hodgkin's Disease
Non Hodgkin's Lymphoma
Procedure: PBSC
Drug: IL-2
Drug: EPOCH II
Phase II

MedlinePlus related topics: Hodgkin's Disease Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy Study
Official Title: A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 49
Study Start Date: February 1995
Estimated Study Completion Date: January 2002
Detailed Description:

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 support.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001430

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 950073, 95-C-0073
Study First Received: November 3, 1999
Last Updated: March 3, 2008
ClinicalTrials.gov Identifier: NCT00001430  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
IL-2
Drug Resistance
Continuous Infusion
Peripheral Stem Cells
MDR

Study placed in the following topic categories:
Lymphatic Diseases
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009