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Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment

Primary Purpose

Leukemia, Lymphoma, Small Intestine Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
clofarabine
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

2 Years - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Cleveland Clinic Taussig Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clofarabine

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose
Response Rate for Participants With Non-Hodgkin's Lymphoma
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)

Secondary Outcome Measures

Participants Evaluated for Toxicity
Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0

Full Information

First Posted
December 27, 2006
Last Updated
April 25, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), University of Rochester, The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00416351
Brief Title
Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Official Title
A Phase I/II Study of Clofarabine in Patients With Relapsed T-Cell and NK-Cell Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 27, 2006 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI), University of Rochester, The Cleveland Clinic

4. Oversight

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Small Intestine Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clofarabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
clofarabine
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Time Frame
2 years
Title
Response Rate for Participants With Non-Hodgkin's Lymphoma
Description
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
Secondary Outcome Measure Information:
Title
Participants Evaluated for Toxicity
Description
Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven M. Horwitz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment

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