- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00042822
FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma
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
Status
Betingelser
Intervention / Behandling
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
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
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New York
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New York, New York, Forenede Stater, 10021
- Memorial Sloan-Kettering Cancer Center
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Virginia Klimek, MD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- tilbagevendende grad 3 follikulært lymfom
- tilbagevendende voksent diffust storcellet lymfom
- refraktær anæmi med overskydende blaster
- refraktær anæmi med overskydende blaster i transformation
- kronisk myelomonocytisk leukæmi
- tidligere behandlede myelodysplastiske syndromer
- sekundære myelodysplastiske syndromer
- akut myeloid leukæmi hos voksne med 11q23 (MLL) abnormiteter
- akut myeloid leukæmi hos voksne med inv(16)(p13;q22)
- akut myeloid leukæmi hos voksne med t(15;17)(q22;q12)
- akut myeloid leukæmi hos voksne med t(16;16)(p13;q22)
- akut myeloid leukæmi hos voksne med t(8;21)(q22;q22)
- tilbagevendende akut myeloid leukæmi hos voksne
- ubehandlet akut myeloid leukæmi hos voksne
- recidiverende voksent diffust små spaltet celle lymfom
- recidiverende voksent diffust blandet celle lymfom
- tilbagevendende grad 1 follikulært lymfom
- tilbagevendende grad 2 follikulært lymfom
- myelodysplastisk/myeloproliferativ neoplasma, uklassificerbar
- atypisk kronisk myeloid leukæmi, BCR-ABL1 negativ
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Sygdom
- Knoglemarvssygdomme
- Hæmatologiske sygdomme
- Forstadier til kræft
- Lymfom
- Syndrom
- Myelodysplastiske syndromer
- Leukæmi
- Præleukæmi
- Myeloproliferative lidelser
- Myelodysplastisk-myeloproliferative sygdomme
- Antineoplastiske midler
- Antibiotika, antineoplastisk
- Romidepsin
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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