- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00005580
Bryostatin + Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma
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
Intervention / Behandling
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
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
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
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Steven Grant, MD, Massey Cancer Center
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
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
- B-celle kronisk lymfatisk leukæmi
- stadium I kronisk lymfatisk leukæmi
- recidiverende voksent diffust små spaltet celle lymfom
- Waldenstrom makroglobulinæmi
- tilbagevendende grad 1 follikulært lymfom
- tilbagevendende grad 2 follikulært lymfom
- tilbagevendende marginal zone lymfom
- tilbagevendende lille lymfocytisk lymfom
- ekstranodal marginal zone B-celle lymfom af slimhinde-associeret lymfoid væv
- nodal marginal zone B-celle lymfom
- milt marginal zone lymfom
- tilbagevendende kappecellelymfom
- refraktær kronisk lymfatisk leukæmi
- stadium II kronisk lymfatisk leukæmi
- stadium III kronisk lymfatisk leukæmi
- stadium IV kronisk lymfatisk leukæmi
- tilbagevendende kutant T-celle non-Hodgkin lymfom
- tilbagevendende voksen T-celle leukæmi/lymfom
- tilbagevendende mycosis fungoides/Sezary syndrom
- refraktær hårcelleleukæmi
- prolymfocytisk leukæmi
- T-celle stor granulær lymfocyt leukæmi
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesygdomme
- Immunproliferative lidelser
- Leukæmi, B-celle
- Lymfom
- Leukæmi
- Lymfom, Non-Hodgkin
- Leukæmi, lymfatisk, kronisk, B-celle
- Leukæmi, lymfoid
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Adjuvanser, immunologiske
- Fludarabin
- Fludarabin phosphat
- Bryostatin 1
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
-
University of Colorado, DenverNational Cancer Institute (NCI)Afsluttet
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)AfsluttetMyelodysplastiske syndromer | LeukæmiForenede Stater
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)AfsluttetMyelom og plasmacelle-neoplasmaForenede Stater
-
National Cancer Institute (NCI)Afsluttet
-
Cancer Research UKAfsluttet
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)AfsluttetHoved- og halskræftForenede Stater
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)AfsluttetLymfomForenede Stater
-
Fundacion para la Investigacion Biomedica del Hospital...Afsluttet
-
National Cancer Institute (NCI)AfsluttetÆggelederkræft | Stadie IV Ovarieepitelkræft | Primær peritoneal kræft | Tilbagevendende ovarieepitelkræft | Stadie III OvarieepitelkræftForenede Stater
-
Icahn School of Medicine at Mount SinaiNational Cancer Institute (NCI)AfsluttetLivmoderhalskræftForenede Stater