A Phase I/II Study of Clofarabine in Patients With Relapsed T-Cell and NK-Cell Lymphomas
2 Years
N/A
Both
Leukemia, Lymphoma, Small Intestine Cancer
Trial Information
A Phase I/II Study of Clofarabine in Patients With Relapsed T-Cell and NK-Cell Lymphomas
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose (Phase I)
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Steven M. Horwitz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
06-065
NCT ID:
NCT00416351
Start Date:
June 2006
Completion Date:
July 2014
Related Keywords:
- Leukemia
- Lymphoma
- Small Intestine Cancer
- anaplastic large cell lymphoma
- angioimmunoblastic T-cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult T-cell leukemia/lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- adult nasal type extranodal NK/T-cell lymphoma
- prolymphocytic leukemia
- childhood nasal type extranodal NK/T-cell lymphoma
- recurrent childhood lymphoblastic lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- small intestine lymphoma
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Intestinal Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
