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Bryostatin + Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma

23. februar 2010 opdateret af: Virginia Commonwealth University

Phase I Study of Bryostatin 1 (NSC 339555) and Fludarabine in Patients With Chronic Lymphocytic Leukemia and Indolent Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus fludarabine in treating patients who have chronic lymphocytic leukemia or relapsed, indolent non-Hodgkin's lymphoma.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the toxic effects and maximum tolerated dose of bryostatin 1 and fludarabine in patients with symptomatic or advanced chronic lymphocytic leukemia or relapsed indolent non-Hodgkin's lymphoma.
  • Monitor apoptosis, differentiation, and protein kinase C activity in leukemic lymphocytes exposed in vivo to bryostatin 1 and fludarabine.
  • Observe the antitumor activity of this combination therapy in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to one of two treatment groups.

  • Group I: Patients receive bryostatin 1 IV over 24 hours followed by fludarabine IV over 30 minutes daily on days 1-5.
  • Group II: Patients receive fludarabine IV over 30 minutes daily on days 1-5 followed by bryostatin 1 IV over 24 hours.

In both groups, courses repeat every 4 weeks for patients with stable or responding disease.

Cohorts of 3-6 patients receive escalating doses of fludarabine and bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD for fludarabine is determined, the dose of bryostatin 1 is escalated.

PROJECTED ACCRUAL: Approximately 30-60 patients will be accrued for this study within 3 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

54

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

    • New York
      • New York, New York, Forenede Stater, 10021
        • New York Presbyterian Hospital - Cornell Campus
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Fox Chase Cancer Center
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298-0037
        • Massey Cancer Center

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed chronic lymphocytic leukemia

    • Stage I (symptomatic or with bulky lymphadenopathy)
    • Stage II, III, or IV
    • Prior chemotherapy allowed, including fludarabine or other purine nucleoside analog therapy OR
  • Histologically confirmed indolent non-Hodgkin's lymphoma

    • Progressive or relapsed following chemotherapy
  • Includes the following histologies:

    • B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/lymphomas

      • Lymphoplasmacytoid lymphoma (Waldenstrom's)/immunocytoma
      • Mantle cell lymphoma
      • Follicular lymphoma

        • Small cell
        • Mixed small and large cell
        • Diffuse (predominately small cell type)
      • Marginal zone B-cell lymphoma

        • Extranodal (MALT-type with or without monocytoid B-cells)
        • Provisional subtype: nodal (with or without monocytoid B-cells)
      • Provisional entity: splenic marginal zone lymphoma (with or without villous lymphocytes)
      • Hairy cell leukemia
  • Peripheral T-cell and NK-cell neoplasms

    • T-cell chronic lymphocytic leukemia/polylymphocytic leukemia
    • Large granular lymphocyte leukemia

      • T-cell type
      • NK-cell type
    • Mycosis fungoides/Sezary's syndrome (cutaneous T-cell lymphoma)
  • No CNS disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,000/mm3
  • Platelet count at least 75,000/mm3
  • Hemoglobin at least 8 g/dL
  • Coombs negative

Hepatic:

  • AST/ALT no greater than 2.5 times upper limit of normal
  • Bilirubin no greater than 2 mg/mL

Renal:

  • Creatinine clearance at least 40 mL/min

Other:

  • No concurrent neurologic condition
  • No other concurrent medical condition that would preclude study
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent systemic immunoglobulin therapy
  • No prior bone marrow or peripheral stem cell transplantation

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior systemic chemotherapy

Endocrine therapy:

  • No concurrent systemic glucocorticoid therapy

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No other concurrent anticancer therapy

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: Ikke-randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Studiestol: Steven Grant, MD, Massey Cancer Center

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.

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

1. september 1998

Primær færdiggørelse (Faktiske)

1. august 2006

Studieafslutning (Faktiske)

1. august 2006

Datoer for studieregistrering

Først indsendt

2. maj 2000

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. februar 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. februar 2010

Sidst verificeret

1. februar 2010

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CDR0000066433
  • P30CA016059 (U.S. NIH-bevilling/kontrakt)
  • MCV-CCHR-9801-2C
  • NCI-T97-0116

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 .

Kliniske forsøg med bryostatin 1

Abonner