Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
University of Rochester
The Cleveland Clinic
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00416351
First received: December 27, 2006
Last updated: March 8, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Small Intestine Cancer |
Drug: clofarabine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of Clofarabine in Patients With Relapsed T-Cell and NK-Cell Lymphomas |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- Maximum tolerated dose (Phase I) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 29 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Clofarabine
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.
|
Drug: clofarabine |
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 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.
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416351
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
University of Rochester
The Cleveland Clinic
Investigators
| Principal Investigator: | Steven M. Horwitz, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00416351 History of Changes |
| Other Study ID Numbers: | 06-065, P30CA008748, MSKCC-06065 |
| Study First Received: | December 27, 2006 |
| Last Updated: | March 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Lymphoma, Non-Hodgkin Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Ileal Diseases Jejunal Diseases Clofarabine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013