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

NCT00416351 | Completed Phase 1 Results

• 3 other identifiers: 06-065P30CA008748MSKCC-06065
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose

  2 years

• 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 Outcomes (1)

• Participants Evaluated for Toxicity

  2 years

Study Arms (1)

Clofarabine

EXPERIMENTAL

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

Interventions

clofarabine DRUG

Clofarabine

Eligibility Criteria

• Age: 2 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• University of Rochester: collaborator
• The Cleveland Clinic: collaborator

Study Sites (3)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Leukemia; Lymphoma; Lymphoma, Large-Cell, Anaplastic; Immunoblastic Lymphadenopathy; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Mycosis Fungoides; Sezary Syndrome; Lymphoma, Extranodal NK-T-Cell; Leukemia, Prolymphocytic; Lymphoma, T-Cell, Cutaneous

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphadenopathy; Leukemia, Lymphoid

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides

Results Point of Contact

• Title: Dr. Steven Horowitz MD
• Organization: Memorial Sloan Kettering Cancer Center

horwitzs@mskcc.org

646-608-2680

Study Officials

• Steven M. Horwitz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: June 27, 2006
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 17, 2022
• Results First Posted: May 17, 2022

Record last verified: 2021-03

Locations

US (3)