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

Lymphoma Clinical Trial

Official title:

A Phase I/II Study of Clofarabine in Patients With Relapsed T-Cell and NK-Cell Lymphomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416351
• Other study ID #: 06-065
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 27, 2006
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Neoplasms
• Leukemia
• Lymphoma
• Small Intestine Cancer

Intervention

Drug:
• clofarabine

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI), The Cleveland Clinic, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose		2 years
Primary	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)	2 years
Secondary	Participants Evaluated for Toxicity	Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0	2 years

External Links

•   Memorial Sloan Kettering Cancer Center