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.

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

Phase II Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell NHL > 60 Years or With Compromised Cardiac Status

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00333008
• Other study ID #: LY-012006
• Status: Recruiting
• Phase: Phase 2
• First received: May 31, 2006
• Last updated: September 25, 2006
• Start date: May 2006

Study information

• Verified date: September 2006
• Source: The Alvin and Lois Lapidus Cancer Institute
• Contact: Pam Nickoles, RN, BSN
• Phone: 410-601-0729
• Email: pnickole[@]lifebridgehealth.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 rituximab) in NHL.

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 by the American Society of Clinical Oncology as a "special population" due to their disease characteristics, additional health problems, and need for aggressive supportive care strategies to reduce morbidity and mortality. The combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) remains as standard therapy for the treatment of DLBCL, but elderly patients tend to tolerate the CHOP therapy less when compared to younger patients. Cardiac toxicity, as well as decrease in blood counts, are the most common side effects in the elderly population. For these reasons, many doctors are reluctant to use standard combinations and doses of chemotherapy in the elderly for fear of increased morbidity. DLBCL in the elderly is also somewhat unique in that the elderly patients appear to have more aggressive disease and poor overall outcome. In order to maximize the tolerability of treatment and thus potentially enhance overall treatment success in this population, it is necessary to look at alternative treatments. This clinical trial is based on currently accepted standard NHL therapy (CHOP-Rituximab) in which Doxil is substituted for Adriamycin. Growth factor will be used for support of acceptable blood counts. Chemotherapy regimens that include rituximab are now the gold standard for treatment of DLBCL. If indeed, delivering full dose chemotherapy without treatment delays leads to higher remission and cure rates, then this offers a significant proportion of NHL patients who are elderly a chance for cure rather than providing treatment for comfort measures while preserving quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Doxil

• Cyclophosphamide

• Vincristine

• Prednisone

• Rituximab

• Pegfilgrastim

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Northwest Hospital Center	Randallstown	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
The Alvin and Lois Lapidus Cancer Institute	Ortho Biotech Products, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v3.0
Primary	Efficacy: tumor evaluations every three (q 3) cycles

External Links

•   The Alvin and Lois Lapidus Cancer Institute; Protocols