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Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome

13. november 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

33

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lenalidomid
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Response to Treatment
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients Who Experience Toxicity as Assessed by NCI CTCAE v3.0
Tidsramme: 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

Andre resultatmål

Resultatmål
Tidsramme
Specific Immune Effector Cell Recruitment and Augmentation of Antitumor Response at Baseline and Day 15 of Course 1 (Northwestern University Only)
Tidsramme: 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
Tidsramme: After all patients have completed 1 course
After all patients have completed 1 course

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Northwestern University

Samarbejdspartnere

National Cancer Institute (NCI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. april 2005

Primær færdiggørelse (Faktiske)

5. april 2010

Studieafslutning (Faktiske)

17. maj 2013

Datoer for studieregistrering

Først indsendt

25. april 2007

Først indsendt, der opfyldte QC-kriterier

25. april 2007

Først opslået (Skøn)

27. april 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. november 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NU 04H5
  • P30CA060553 (U.S. NIH-bevilling/kontrakt)
  • NU-04H5

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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