Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Cyclosporine may improve low blood counts caused by hematologic cancer.

PURPOSE: Phase II trial to study the effectiveness of cyclosporine in treating patients who have low blood counts caused by hematologic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclosporine; Cyclosporins

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of T-cell large granular lymphocytic leukemia

• Increased numbers of large granular lymphocytes in peripheral blood smears

• CD3+CD8+CD57+ immunophenotype by flow cytometry AND

• CD3+CD57+ cell count at least 2,000/mm^3 OR

• CD3+CD57+ cell count at least 500/mm^3 with clonal T-cell receptor beta gene rearrangement

• Patients must have at least 1 of the following:

• Severe neutropenia (absolute neutrophil count (ANC) less than 500/mm^3)

• Neutropenia (ANC less than 1,000/mm^3) and recurrent infections

• Anemia (hemoglobin less than 9 g/dL)

• Thrombocytopenia (platelet count less than 50,000/mm^3)

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• NCI CTC 0-3

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

• Creatinine no greater than 2 times ULN

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Endocrine therapy:

• No concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)

• No concurrent dexamethasone or other steroidal antiemetics

Other:

• No prior cyclosporine therapy for this leukemia