- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00024180
FR901228 in Treating Patients With Hematologic Cancer
A Phase I Study of Depsipeptide in Selected Hematologic Malignancies (NSC 630176)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer.
Studieoversigt
Detaljeret beskrivelse
OBJECTIVES:
- Determine the in vivo biologic effect of FR901228 (depsipeptide) in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, acute myeloid leukemia, or acute lymphoblastic leukemia.
- Determine the pharmacokinetics and cellular pharmacodynamics of this drug in these patients.
- Determine any preliminary anti-tumor activity of this drug in these patients.
OUTLINE: This is a dose-decreasing, multicenter study. Patients are stratified according to disease (chronic lymphocytic leukemia and small lymphocytic lymphoma vs acute myeloid leukemia and acute lymphoblastic leukemia).
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Cohorts of 10 patients per stratum receive decreasing doses of FR901228 until the minimal active dose is determined. If 5 or more patients show clinical or biological response, the subsequent cohort is treated at a lower dose. If fewer than 5 patients respond, the subsequent cohort is treated at a higher dose.
PROJECTED ACCRUAL: A minimum of 20 patients (10 per stratum) will be accrued for this study.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Ohio
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Columbus, Ohio, Forenede Stater, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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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:
Diagnosis of one of the following hematologic malignancies:
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL) (including Waldenstrom's macroglobulinemia)
- Acute myeloid leukemia (AML)
- Acute lymphoblastic leukemia (ALL)
Stratum I (CLL and SLL):
- Received at least one prior therapy containing a purine analog OR
- Received another form of therapy (including alkylating agents) due to history of severe autoimmune disease, requirement for chronic corticosteroid, or other contraindication to purine analog therapy
Stratum II (AML and ALL):
- Primary refractory or relapsed leukemia within the past year that is not amenable to curative therapy
- OR
Untreated or previously treated poor-risk leukemia defined by any of the following:
- 65 years of age and over
- Poor-risk candidates for aggressive chemotherapy
- Poor-risk cytogenetics (for AML, karyotype abnormalities other than t(8;21), inv(16), t(15;17))
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
Stratum I only:
- No uncontrolled autoimmune hemolytic anemia
- No idiopathic thrombocytopenic purpura
Stratum II only:
- WBC no greater than 10,000/mm^3 OR
- WBC no greater than 40,000/mm^3 that is stable for at least 1 week (may be sustained by hydroxyurea through the first week of study)
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- ALT and AST no greater than 3 times upper limit of normal
Renal:
- Creatinine less than 2.0 mg/dL
Cardiovascular:
- Ejection fraction at least 50% by MUGA
- No myocardial infarction or unstable angina within the past 6 months
- No prior unstable ventricular or supraventricular cardiac arrhythmias
Other:
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other medical or psychiatric problem that would preclude study
Stratum I only:
- No active infection requiring oral or IV antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 28 days since prior chemotherapy (except hydroxyurea)
- At least 6 weeks since prior nitrosoureas
- At least 8 weeks since prior UCN-01 (unless plasma UCN-01 level less than 1 uM)
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- At least 28 days since prior radiotherapy
Surgery:
- At least 28 days since prior major surgery
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Guido Marcucci, MD, Ohio State University Comprehensive Cancer Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000068898
- OSU-00H0350
- NCI-27
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