- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00019838
UCN-01 and Fludarabine in Treating Patients With Recurrent or Refractory Lymphoma or Leukemia
Phase I and Pharmacokinetic Study of UCN-01 and Fludarabine in Relapsed or Refractory Low-Grade Lymphoid Malignancies
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when given with UCN-01 in treating patients with recurrent or refractory low-grade lymphoma or leukemia.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- Determine the maximum tolerated dose and toxic effects of fludarabine when administered with UCN-01 in patients with recurrent or refractory low-grade or indolent lymphoid malignancies.
- Determine, preliminarily, the activity of this treatment regimen in these patients.
- Assess the pharmacokinetics of this treatment regimen in these patients.
OUTLINE: This is a dose-escalation study of fludarabine.
Patients receive UCN-01 IV over 72 hours on days 1-3 alone during course 1 and over 36 hours on days 1-2 during courses 2-7. Patients also receive fludarabine IV over 30 minutes beginning on day 1 and continuing for up to 5 days during courses 2-7. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of fludarabine 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.
Patients are followed every 2 months for 6 months, every 3 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
Studietyp
Fas
- Fas 1
Kontakter och platser
Studieorter
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Maryland
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Bethesda, Maryland, Förenta staterna, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Bethesda, Maryland, Förenta staterna, 20892
- NCI - Center for Cancer Research
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent or refractory low-grade or indolent lymphoid malignancies requiring systemic therapy, including the following:
- Grade I or II follicular small cleaved cell lymphoma
- Small lymphocytic lymphoma/leukemia subtypes (chronic lymphocytic leukemia)
- Mantle cell lymphoma
- Waldenstrom's macroglobulinemia
- Lymphoplasmacytoid
- Marginal zone (nodal, extranodal, or splenic subtypes)
- Hairy cell leukemia
Transformed indolent subtypes allowed provided 1 of the following criteria are met:
- Previously treated with a doxorubicin-containing regimen
- No rapidly progressing disease that threatens vital functions
- Measurable disease
- No active leptomeningeal or parenchymal CNS lymphoma 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:
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 50,000/mm^3
- No active Coomb's-positive hemolytic anemia
Hepatic:
- Total bilirubin less than 2.0 mg/dL (unless elevation is due to Gilbert's disease and direct bilirubin is normal)
Renal:
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No angina
- No congestive heart failure
- No myocardial infarction within the past 6 months
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No insulin-dependent diabetes mellitus
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- More than 3 weeks since prior systemic chemotherapy and recovered
Endocrine therapy:
- More than 3 weeks since prior systemic steroid therapy and recovered
Radiotherapy:
- Not specified
Surgery:
- Not specified
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Wyndham H. Wilson, MD, PhD, National Cancer Institute (NCI)
Publikationer och användbara länkar
Allmänna publikationer
- Marti GE, Stetler-Stevenson M, Grant ND, White T, Figg WD, Tohnya T, Jaffe ES, Dunleavy K, Janik JE, Steinberg SM, Wilson WH. Phase I trial of 7-hydroxystaurosporine and fludararbine phosphate: in vivo evidence of 7-hydroxystaurosporine induced apoptosis in chronic lymphocytic leukemia. Leuk Lymphoma. 2011 Dec;52(12):2284-92. doi: 10.3109/10428194.2011.589547. Epub 2011 Jul 12.
- Wilson WH, Gutierrez M, Stetler-Stevenson M, et al.: Phase I trial of 7-hydroxystaurosporine (UCN-01) and fludararbine phosphate (FAMP); in vivo evidence of UCN-01 induced apoptosis in CLL. [Abstract] Blood 96 (11 Pt 1): A-3268, 756a, 2000.
Studieavstämningsdatum
Studera stora datum
Studiestart
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- återkommande follikulärt lymfom grad 1
- återkommande follikulärt lymfom grad 2
- återkommande lymfom i marginalzonen
- återkommande små lymfocytiska lymfom
- extranodal marginalzon B-cellslymfom i slemhinneassocierad lymfoid vävnad
- nodal marginalzon B-cells lymfom
- marginalzonens lymfom i mjälten
- återkommande mantelcellslymfom
- refraktär kronisk lymfatisk leukemi
- refraktär hårcellsleukemi
- Waldenström makroglobulinemi
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Lymfom
- Leukemi
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Proteinkinashämmare
- Fludarabin
- Fludarabinfosfat
- 7-hydroxistaurosporin
Andra studie-ID-nummer
- CDR0000067252
- NCI-99-C-0127
- NCI-T99-0022
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