Overview

Gemcitabine in Treating Patients With Recurrent Chronic Lymphocytic Leukemia

Status:
Completed

Trial end date:
2008-04-01

Target enrollment:
0

Participant gender:
All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have recurrent chronic lymphocytic leukemia.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborator:

National Cancer Institute (NCI)

Treatments:

Gemcitabine

Criteria

DISEASE CHARACTERISTICS: Diagnosis of B-cell chronic lymphocytic leukemia manifested by all
of the following: Minimum threshold peripheral lymphocyte count of at least 5,000/mm3 Small
to medium sized peripheral blood lymphocytes with no greater than 55% prolymphocytes Bone
marrow aspirate and biopsy containing at least 30% lymphoid cells Immunophenotypic and
biopsy evaluation of peripheral blood lymphocytes demonstrating monoclonality of B
lymphocytes B-cell markers with CD5 antigen (e.g., T-1, T-101) in the absence of other pan
T-cell markers (e.g., CD3, CD2) Expression of CD19, CD20, and CD23 B cell surface markers
B-cell expression of kappa or lambda light chains Active disease with at least one of the
following criteria: One or more disease related symptoms: At least 10% weight loss within
the past 6 months Fever greater than 100.5 F for at least 2 weeks without evidence of
infection Night sweats without evidence of infection Evidence of progressive marrow failure
as manifested by the development of or worsening of anemia (hemoglobin less than 11.0 g/dL)
and/or thrombocytopenia (platelet count less than 100,000/mm3) (i.e., any stage III or IV
disease) Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid
therapy Massive (i.e., greater than 6 cm below the left costal margin) or progressive
splenomegaly (i.e., a greater than 50% increase over two months) Massive (i.e., greater
than 10 cm in longest diameter) or progressive lymphadenopathy (i.e., a greater than 50%
increase over two months) Progressive lymphocytosis with an increase of greater than 50%
over a 2 month period (unrelated to corticosteroids) or an anticipated doubling time of
less than 6 months No marked hypogammaglobulinemia or the development of a monoclonal
protein in the absence of any criteria for active disease Previously treated with at least
a fludarabine or cladribine based regimen and a prior alkylating agent with evidence of
recurrent or progressive disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: See Disease Characteristics Platelet count at least 75,000/mm3
Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater
than 1.5 times ULN (unless due to hemolysis or chronic lymphocytic leukemia) Renal:
Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association
class III or IV heart disease No myocardial infarction within the past month Other: No
uncontrolled infection HIV negative No other active malignancy Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease
Characteristics No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior
radiotherapy Surgery: At least 4 weeks since prior major surgery