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About
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.
Full description
OBJECTIVES:
Primary
OUTLINE: This is a phase I, non-randomized, dose-escalation study followed by an open-label, phase II study.
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.
After completion of study treatment, patients are followed every 3 months for 2 years.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed T-cell or natural killer (NK)-cell lymphoma, including any of the following subtypes:
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
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)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
At least 3 weeks since prior therapy, including any of the following:
Concurrent stable-dose corticosteroids allowed
No colony-stimulating factor therapy during the first course of study therapy
Primary purpose
Allocation
Interventional model
Masking
29 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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