Completed

Phase 2
All Genders
ID00001430

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

Led by National Cancer Institute (NCI) · Updated on 2008-03-04

49

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 1 location

1

National Cancer Institute (NCI)

Bethesda, Maryland, United States, 20892

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

T-cell regeneration after bone marrow transplantation: differential CD45 isoform expression on thymic-derived versus thymic-independent progeny.

C L Mackall, L Granger, M A Sheard...

https://pubmed.ncbi.nlm.nih.gov/7691265
A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas | DecenTrialz