search
Back to results

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

Primary Purpose

Hodgkin's Disease, Non Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PBSC
IL-2
EPOCH II
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin's Disease focused on measuring IL-2, Drug Resistance, Continuous Infusion, Peripheral Stem Cells, MDR

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001430
Brief Title
A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas
Official Title
A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
January 2002
Overall Recruitment Status
Completed
Study Start Date
February 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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'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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Disease, Non Hodgkin's Lymphoma
Keywords
IL-2, Drug Resistance, Continuous Infusion, Peripheral Stem Cells, MDR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
49 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
PBSC
Intervention Type
Drug
Intervention Name(s)
IL-2
Intervention Type
Drug
Intervention Name(s)
EPOCH II

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7687667
Citation
Wilson WH, Bryant G, Bates S, Fojo A, Wittes RE, Steinberg SM, Kohler DR, Jaffe ES, Herdt J, Cheson BD, et al. EPOCH chemotherapy: toxicity and efficacy in relapsed and refractory non-Hodgkin's lymphoma. J Clin Oncol. 1993 Aug;11(8):1573-82. doi: 10.1200/JCO.1993.11.8.1573.
Results Reference
background
PubMed Identifier
8105034
Citation
Vose JM, Anderson JR, Kessinger A, Bierman PJ, Coccia P, Reed EC, Gordon B, Armitage JO. High-dose chemotherapy and autologous hematopoietic stem-cell transplantation for aggressive non-Hodgkin's lymphoma. J Clin Oncol. 1993 Oct;11(10):1846-51. doi: 10.1200/JCO.1993.11.10.1846.
Results Reference
background
PubMed Identifier
7691265
Citation
Mackall CL, Granger L, Sheard MA, Cepeda R, Gress RE. T-cell regeneration after bone marrow transplantation: differential CD45 isoform expression on thymic-derived versus thymic-independent progeny. Blood. 1993 Oct 15;82(8):2585-94.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs