Epirubicin and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Sponsor

Fox Chase Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00062296

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining epirubicin with rituximab may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with rituximab in treating patients who have relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma	Biological: rituximab Drug: epirubicin hydrochloride	Phase 2

Detailed Description

OBJECTIVES:

Determine the response rate, time to progression, and overall survival of patients with refractory or relapsed B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with epirubicin and rituximab.
Determine the toxicity of this regimen in these patients.
Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a non-randomized, open-label, multicenter study.

Patients receive epirubicin IV over 3-5 minutes once weekly for 6 weeks. Patients also receive rituximab IV on weeks 2 and 5 during course 1 and then on weeks 1 and 4 for all remaining courses. Treatment repeats every 8 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 18-38 patients will be accrued for this study within 2.5-3 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Epirubicin and Rituximab in Relapsed and Refractory B-Cell Non-Hodgkin's Lymphoma and CLL

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Aug 1, 2005

Actual Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed B-cell non-Hodgkin's lymphoma (any grade) or chronic lymphocytic leukemia meeting 1 of the following criteria:
Primary refractory disease
Disease progression after at least 1 but no more than 4 prior cytotoxic chemotherapy regimens
Rituximab administered alone is not considered 1 prior regimen
High-dose chemotherapy with stem cell support is considered 1 prior regimen
Bidimensionally measurable or evaluable disease outside prior irradiation port
No clinical evidence of CNS involvement

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Neutrophil count at least 2,000/mm^3*
Platelet count at least 100,000/mm^3* NOTE: *Unless due to bone marrow involvement

Hepatic

Bilirubin no greater than 1.5 mg/dL
SGOT and SGPT no greater than 2 times upper limit of normal (ULN)

Renal

Creatinine no greater than 2 times ULN

Cardiovascular

No unstable angina
No uncontrolled congestive heart failure
LVEF at least 45%

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study treatment
HIV negative
No other concurrent primary malignancy except basal cell or squamous cell skin cancer, carcinoma in situ, or localized solid tumors cured more than 5 years ago
No acute infection requiring systemic therapy
No confusion, disorientation, or major psychiatric illness that would preclude understanding of informed consent