This trial is active, not recruiting.

Conditions leukemia, lymphoma, small intestine cancer
Treatment clofarabine
Phase phase 1/phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date June 2006
End date July 2017
Trial size 29 participants
Trial identifier NCT00416351, 06-065, MSKCC-06065, P30CA008748


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels.

Primary Outcomes

Maximum tolerated dose (Phase I)
time frame: 2 years
Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II)
time frame: 2 years

Secondary Outcomes

Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0
time frame: 2 years

Eligibility Criteria

Male or female participants from 2 years up to 120 years old.

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

Additional Information

Official title A Phase I/II Study of Clofarabine in Patients With Relapsed T-Cell and NK-Cell Lymphomas
Principal investigator Steven M. Horwitz, MD
Description OBJECTIVES: Primary - Determine the maximum tolerated dose of clofarabine in patients with relapsed or refractory T-cell or natural killer-cell lymphoma. - Determine the toxicity of this drug in these patients. - Determine, preliminarily, the efficacy of this drug, in terms of response rate, in these patients. OUTLINE: This is a phase I, non-randomized, dose-escalation study followed by an open-label, phase II study. - Phase I: Patients receive clofarabine IV over 1 hour once daily on days 1-3. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) or complete response (CR) may receive 2 additional courses of treatment. Patients with PR or CR after completing 4 courses of therapy may receive 2 additional courses. Cohorts of 1-6 patients receive escalating doses of clofarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive clofarabine as in phase I at the MTD determined in phase I. After completion of study treatment, patients are followed every 3 months for 2 years.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.