Status:
COMPLETED
A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Hodgkin's Disease
Non Hodgkin's Lymphoma
Eligibility:
All Genders
Phase:
PHASE2
Brief 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...
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...
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.
Key Trial Info
Start Date :
February 1 1995
Trial Type :
INTERVENTIONAL
End Date :
January 1 2002
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00001430
Start Date
February 1 1995
End Date
January 1 2002
Last Update
March 4 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892