Status:
UNKNOWN
A Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma (NHL)> 60 Years or With Compromised Cardiac Status.
Lead Sponsor:
The Alvin and Lois Lapidus Cancer Institute
Collaborating Sponsors:
Ortho Biotech Products, L.P.
Conditions:
Diffuse Large B Cell Lymphoma
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the feasibility and tolerability of delivering a full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine, prednisone, and rituxi...
Detailed Description
Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of non-Hodgkin's lymphoma with more than half of the patients being over the age of 60 years. Elderly patients with cancer are defined b...
Eligibility Criteria
Inclusion
- 60 years old and older or 18 years old and older with significant/potential cardiac morbidity
- Diagnosis of diffuse large B cell lymphoma, Ann Arbor stage I-IV, any International Prognostic Index (IPI) score.
- Previously untreated
- New York Heart Association (NYHA) classification of Class III or better
- Baseline ejection fraction (EF) \> 25%
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
- Unless attributable to NHL: absolute neutrophil count (ANC) \> 1500/uL, platelets \> 100,000/uL; hemoglobin \> 9.0 g/dl
- Bilirubin \< 1.5 mg/dL (unless related to lymphoma)
- Hepatic: transaminases \< 2.5 x upper limit of normal (ULN) (unless related to lymphoma)
- Creatinine \< 2.5 mg/dl (unless related to lymphoma)
Exclusion
- No HIV+ individuals
- No primary central nervous system (CNS) lymphoma
- No pregnant or lactating women
- No serious active infection
- History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00333008
Start Date
May 1 2006
Last Update
September 26 2006
Active Locations (2)
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1
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
2
Northwest Hospital Center
Randallstown, Maryland, United States, 21133