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Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome

13 novembre 2020 aggiornato da: Northwestern University

Phase II Trial of CC-5013 (Lenalidomide, Revlimid®) in Patients With Cutaneous T-Cell Lymphoma

RATIONALE: Lenalidomide may stop the growth of mycosis fungoides/Sezary syndrome by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with relapsed mycosis fungoides/Sezary syndrome.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary

  • Determine the response rate and duration of response in patients with relapsed mycosis fungoides/Sézary syndrome treated with lenalidomide.
  • Determine the progression-free survival of patients treated with this drug.

Secondary

  • Determine the toxicity of this drug in these patients.
  • Correlate the antiangiogenetic and costimulatory effects of this drug with clinical activity in skin biopsies from these patients.
  • Assess the specific immune effector cell recruitment and augmentation of antitumor response in these patients. (Northwestern University only)

OUTLINE: This is a multicenter study.

Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 2 courses. Patients with progressive disease are removed from study. Patients achieving complete response receive 2 additional courses of treatment beyond complete response. Patients achieving partial response or stable disease may continue to receive lenalidomide as above for up to 2 years. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients undergo tissue biopsies at baseline and on day 1 of course 2. Tissue specimens are analyzed for vessel density, presence of adhesion molecules, and immunophenotyping of dermal infiltrate.*

NOTE: *At Northwestern University only, blood and tissue samples from 5-10 patients are collected. Peripheral blood samples are analyzed for immune cell repertoire (CD4+, CD8+ T cells, NK cells, NKT cells, CD4+, CD25+ T-regulatory cells, monocytes, and dendritic cell subsets), cell surface molecules, and for TH1/TH2-associated cytokines, such as interleukin (IL)-2, IL-4, IL-10, IL-12, interferon gamma, and tumor necrosis factor alpha, by flow cytometry at baseline, day 15 of course 1, and at the end of course 1. Immunological activation is assessed by analyzing surface expression of CD45RO and CTLA-4 on CD4+ and CD8+ T cells in blood and skin samples. Skin specimens are stored for future research studies on predictive markers of lenalidomide activity.

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

33

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • Stanford, California, Stati Uniti, 94305-5824
        • Stanford Cancer Center
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
    • Texas
      • Houston, Texas, Stati Uniti, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 120 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

DISEASE CHARACTERISTICS:

  • Histologically confirmed mycosis fungoides/Sézary syndrome

    • Stage IA-IVB disease

  • Must have failed ≥ 1 prior topical treatment, including any of the following:

    • Steroids
    • Nitrogen mustard
    • Retinoids
    • Phototherapy
    • Photochemotherapy
    • Radiotherapy
    • Total skin electron beam

  • Measurable disease with ≥ 1 indicator lesion designated prior to study entry

    • Erythrodermic patients are eligible

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 2.2 mg/dL
  • AST and ALT ≤ 2 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile women must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study therapy
  • Fertile men must use effective contraception during and for ≥ 4 weeks after completion of study therapy
  • No other malignancy within the past 5 years except treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, or surgically removed melanoma in situ of the skin (stage 0), with histologically confirmed free margins of excision and no current evidence of disease
  • No acute infection requiring systemic treatment
  • No known allergic reaction or hypersensitivity to thalidomide

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 4 weeks since prior topical therapy, systemic chemotherapy, or biological therapy
  • No prior stem cell transplantation
  • No other concurrent systemic antipsoriatic or anticancer therapies, including radiotherapy, thalidomide, or other investigational agents
  • No other concurrent topical agents except emollients

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Lenalidomide
Droga: lenalidomide
10 mg daily orally administered on days 1 - 21 followed by 7 days rest of a 28-day cycle, increasing dose by 5 mg every cycle, up to a maximum of 25 mg.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Response to Treatment
Lasso di tempo: After cycle 4 of treatment (1 cycle =28 days)

In general response to treatment is defined as either complete response (CR) or partial response (PR) assessed using Composite Assessment (CA) of index lesion disease severity and is defined as the following:

CR =CA ratio=0/no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (< 5% Sézary cells=not significant). Skin biopsy is required for documentation of CR. Confirmatory CT scans are required, if baseline CTs were abnormal.

PR= CA ratio ≥0.5/no new clinically abnormal lymph nodes/no progression of existing clinically abnormal lymph nodes (<25%)/no new cutaneous tumors/no new pathologically positive lymph nodes or visceral disease in an area previously documented as-ve for at least 4 weeks. In patients with circulating Sézary cells at least a 50% reduction of malignant lymphocytes is required.
After cycle 4 of treatment (1 cycle =28 days)
Progression-free Survival (PFS)
Lasso di tempo: From time of treatment initiation until progression or death from any cause (up to a possible maximum of approximately 6 years)

PFS is defined from the time of treatment initiation until documentation of progressive disease or death from any cause.

Progressive disease is defined as (PD) ≥25% increase in CA ratio, ≥25% increase in no. or area of clinically abnormal lymph nodes/new tumors/new pathologically positive lymph nodes/visceral disease/an increase >25% in no. of Sézary cells.
From time of treatment initiation until progression or death from any cause (up to a possible maximum of approximately 6 years)
Duration of Response (DOR)
Lasso di tempo: From time of initial response until progressive disease (up to approximately 1 year)
DOR is defined as time of initial documentation of response to the time of documentation of progression in patients who achieve either a complete response (CR) and partial response (PR)
From time of initial response until progressive disease (up to approximately 1 year)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Patients Who Experience Toxicity as Assessed by NCI CTCAE v3.0
Lasso di tempo: From treatment initiation until up to 30 days post treatment with possible 4 cycles of initial treatment (1 cycle =28 days) and up to 2 further years of treatment permitted if meeting response criteria

Toxicity is defined as the number of patients who patients who experienced an adverse event that was determined to be at least possibly related to study drug and determined to be a grade 3 or higher in severity as assessed by the Common Terminology Criteria for Adverse Events v3.0 (CTCAE) where generally:

Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
From treatment initiation until up to 30 days post treatment with possible 4 cycles of initial treatment (1 cycle =28 days) and up to 2 further years of treatment permitted if meeting response criteria

Altre misure di risultato

Misura del risultato
Lasso di tempo
Specific Immune Effector Cell Recruitment and Augmentation of Antitumor Response at Baseline and Day 15 of Course 1 (Northwestern University Only)
Lasso di tempo: After all patients have completed thru day 15 of course 1.
After all patients have completed thru day 15 of course 1.
Correlation of Antiangiogenetic and Costimulatory Effects With Clinical Activity at Baseline and After Course 1
Lasso di tempo: After all patients have completed 1 course
After all patients have completed 1 course

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Northwestern University

Collaboratori

National Cancer Institute (NCI)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 aprile 2005

Completamento primario (Effettivo)

5 aprile 2010

Completamento dello studio (Effettivo)

17 maggio 2013

Date di iscrizione allo studio

Primo inviato

25 aprile 2007

Primo inviato che soddisfa i criteri di controllo qualità

25 aprile 2007

Primo Inserito (Stima)

27 aprile 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 dicembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 novembre 2020

Ultimo verificato

1 ottobre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NU 04H5
  • P30CA060553 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NU-04H5

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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