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FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma

14. maj 2011 opdateret af: Memorial Sloan Kettering Cancer Center

A Pilot Study Of FR901228, Or Depsipeptide (NSC #630176) For Adult Patients With Advanced Hematologic Cancers

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have myelodysplastic syndrome, acute myeloid leukemia, or non-Hodgkin's lymphoma.

Studieoversigt

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the pattern of adverse clinical experience in patients with myelodysplastic syndrome, acute myeloid leukemia, or intermediate-grade or follicular non-Hodgkin's lymphoma treated with FR901228 (depsipeptide).
  • Determine the disease response in patients treated with this drug.
  • Determine the pharmacokinetic and pharmacodynamic correlates of this drug, including measurement of serum plasma levels, H3 and H4 acetylation, apoptosis induction, differentiation, and multidrug-resistant (MDR) phenotype expression in these patients.

OUTLINE: Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1 and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 1 year.

Undersøgelsestype

Interventionel

Fase

  • Fase 2

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
        • Memorial Sloan-Kettering 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:

  • One of the following diagnoses:

    • Histologically confirmed refractory or relapsed acute myeloid leukemia (AML)

      • Failed anthracycline-based chemotherapy
      • Ineligible for or refused allogeneic stem cell transplantation
    • Elderly patients with newly diagnosed AML

      • Ineligible for or refused standard chemotherapy
    • Histologically confirmed high-risk myelodysplastic syndromes

      • Eligible subtypes include:

        • Refractory anemia with excess blasts (RAEB)
        • RAEB in transformation
        • Chronic myelomonocytic leukemia
      • Ineligible for or refused allogeneic bone marrow transplantation
    • Histologically confirmed intermediate-grade non-Hodgkin's lymphoma (NHL)

      • Relapsed after high-dose therapy OR
      • Ineligible for allogeneic or autologous stem cell transplantation
      • Evaluable lesions by radiologic study or physical examination
    • Histologically confirmed follicular NHL

      • Progressed after anthracycline-based chemotherapy and rituximab
      • Evaluable lesions by radiologic study or physical examination NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's syndrome)
  • SGOT and SGPT less than 2 times upper limit of normal

Renal

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • Cardiac ejection fraction greater than 50%
  • No cardiac hypertrophy
  • No known conduction heart disease
  • No New York Heart Association class III or IV heart disease that would make it difficult to assess patient during study participation
  • No significant prior heart disease
  • No significant prior secondary or tertiary heart block
  • No significant prior atrial or ventricular arrhythmia requiring therapeutic intervention or antiarrhythmics for rate control

Pulmonary

  • No severe debilitating pulmonary disease that would make it difficult to assess patient during study participation

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after study participation
  • Potassium ≥ 4.0 mmol/L (supplementation allowed)
  • Magnesium ≥ 2.0 mg/dL (supplementation allowed)
  • No other concurrent active malignancy except basal cell skin cancer
  • No other concurrent significant co-morbidity that would make it difficult to assess patient during study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • At least 2 weeks since prior epoetin alfa or filgrastim (G-CSF)
  • At least 4 weeks since prior cytokines
  • No concurrent immunotherapy

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior systemic chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • No other concurrent investigational agents
  • No concurrent drugs that may prolong the QTc interval

    • FR901228 (depsipeptide) may be administered after a 5-half-life washout period following the use of these drugs

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

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Studiestol: Virginia Klimek, MD, Memorial Sloan Kettering 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. maj 2002

Primær færdiggørelse (Faktiske)

1. marts 2005

Datoer for studieregistrering

Først indsendt

5. august 2002

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. maj 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2011

Sidst verificeret

1. december 2009

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CDR0000069473
  • MSKCC-00116
  • NCI-1715

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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