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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Maryland
-
Bethesda, Maryland, Stati Uniti, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
Bethesda, Maryland, Stati Uniti, 20892
- NCI - Center for Cancer Research
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Wyndham H. Wilson, MD, PhD, National Cancer Institute (NCI)
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- linfoma follicolare ricorrente di grado 1
- linfoma follicolare ricorrente di grado 2
- linfoma ricorrente della zona marginale
- piccolo linfoma linfocitico ricorrente
- linfoma a cellule B della zona marginale extranodale del tessuto linfoide associato alla mucosa
- linfoma a cellule B della zona marginale nodale
- linfoma splenico della zona marginale
- linfoma mantellare ricorrente
- leucemia linfatica cronica refrattaria
- leucemia a cellule capellute refrattaria
- Macroglobulinemia di Waldenstrom
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Linfoma
- Leucemia
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Inibitori della chinasi proteica
- Fludarabina
- Fludarabina fosfato
- 7-idrossistaurosporina
Altri numeri di identificazione dello studio
- CDR0000067252
- NCI-99-C-0127
- NCI-T99-0022
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .