Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works in treating patients with T-cell or natural killer-cell lymphoma that has relapsed or not responded to previous treatment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI); The Cleveland Clinic; University of Rochester
• Treatments: Clofarabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed T-cell or natural killer (NK)-cell lymphoma, including any of the following subtypes:

• Blastic NK-cell lymphoma

• T/NK-cell lymphoma/leukemia

• Adult T-cell lymphoma/leukemia

• T-cell prolymphocytic leukemia

• T-lymphoblastic lymphoma

• Peripheral T-cell lymphoma, not otherwise specified

• Angioimmunoblastic T-cell lymphoma

• Anaplastic large cell lymphoma

• Transformed mycosis fungoides

• Subcutaneous panniculitis-like T-cell lymphoma

• Nasal T/NK-cell lymphoma

• Enteropathy-type T-cell lymphoma

• Hepatosplenic gamma/delta T-cell lymphoma

• Relapsed or refractory disease, meeting both of the following criteria:

• Must have been treated with prior cytotoxic chemotherapy and/or monoclonal antibody therapy

• No standard curative treatment exists

• Allogeneic bone marrow transplantation is not considered standard curative treatment

• Evaluable disease (Phase I)

• Measurable disease, defined as any nodal site or mass lesion ≥ 1.5 cm in longest transverse diameter on physical exam or CT scan OR a measurable extranodal site > 1 cm (Phase II)

• Patients with evaluable blood- or marrow-based disease are eligible

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Absolute neutrophil count ≥ 1,500/mm³ (Phase I)

• Absolute neutrophil count ≥ 500/mm³ (Phase II)

• Platelet count ≥ 100,000/mm³ (Phase I)

• Platelet count ≥ 50,000/mm³ (Phase II)

• Creatinine < 2.0 mg/dL*

• Bilirubin ≤ 2.0 times upper limit of normal (ULN)*

• AST and ALT ≤ 2.5 times ULN*

• No active infection requiring antibiotics

• No New York Heart Association class III or IV congestive heart failure

• No known HIV positivity

• No other active malignancy requiring therapy

• No other serious or life-threatening condition deemed unacceptable by the principal investigator

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception NOTE: *Unless due to lymphoma and patients are entering to the phase II portion of the study

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 3 weeks since prior therapy, including any of the following:

• Interferon

• Antibody therapy

• Retinoids

• Other non-chemotherapeutic treatment

• Concurrent stable-dose corticosteroids allowed

• No colony-stimulating factor therapy during the first course of study therapy