Status:
COMPLETED
Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
University of Rochester
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
2-120 years
Phase:
PHASE1
PHASE2
Brief 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 pha...
Detailed 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 the...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 27 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00416351
Start Date
June 27 2006
End Date
March 1 2021
Last Update
May 17 2022
Active Locations (3)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
2
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
3
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195