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:
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 11, 2014
Last verified: March 2014
  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 2015
Estimated Primary Completion Date: July 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 11, 2014
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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014