Overview

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

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.

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
Arm
(Experimental)
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.
clofarabine

Primary Outcomes

Measure
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

Measure
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.