Search / Trial NCT00001430

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

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

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Il 2 Drug Resistance Continuous Infusion Peripheral Stem Cells Mdr

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 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.

Attachments

readout_NCT00001430_2023-12-10.pdf

4.5 MB

NCT00001430_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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