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

NCT ID: NCT00416351

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-27
• Study Completion Date: 2021-03-01

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.

Conditions

Leukemia; Lymphoma; Small Intestine Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

clofarabine

Intervention Type: DRUG

Interventions

clofarabine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven M. Horwitz, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

P30CA008748

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSKCC-06065

Identifier Type: -

Identifier Source: secondary_id

06-065

Identifier Type: -

Identifier Source: org_study_id