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Phase II Study of UCN-01 in Relapsed or Refractory Systemic Anaplastic Large Cell and Mature T-Cell Lymphomas

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Ce qui est testé

UCN-01 (7-hydroxystaurosporine)

Médicament
Qui peut participer

Maladies hématologiques et lymphatiques+8

+ Maladies du Système Immunitaire

+ Troubles immunoprolifératifs

À partir de 12 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Phase 2
Interventionnel
Date de début : avril 2004
Voir le détail du protocole

Résumé

Sponsor principalNational Cancer Institute (NCI)
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 5 avril 2004

Date à laquelle le premier participant a commencé l'étude.

Background: * UCN-01 (7-hydroxystaurosporine), a non-specific protein kinase C (PKC) inhibitor appears to have several mechanisms of action including protein kinase C (PKC) isoenzyme inhibition and cyclin dependent kinase activation and inhibition. * We have demonstrated that cell lines derived from T-cell lymphomas, including those with the t (2; 5) translocation, are very sensitive to UCN-01. The t (2; 5) translocation, associated with three quarters of cases of anaplastic large cell lymphomas (ALCL), is an oncogenic fusion protein - nucleophosmin-anaplastic lymphoma kinase (NPM-ALK). * Anaplastic lymphoma receptor tyrosine kinase (ALK) is one potential target for UCN-01 action, and anaplastic large cell lymphoma (ALCL) derived SUDHL-1 cells containing the NPM-ALK protein have been shown to be very sensitive to UCN-01. Objectives: * To assess the clinical response to UCN-01 and progression-free and overall survival in patients with relapsed or refractory systemic Anaplastic Large Cell and other mature T-cell Lymphomas. * To assess the effect of UCN-01 on ALK expression in ALCL cells. * To assess the effect of UCN-01 on soluble tetrameric antibody complexes (TAC) (CD25). * To evaluate mature T-cell lymphoma malignant cells by complimentary deoxyribonucleic acid (cDNA) microarray. Eligibility: * Relapsed or refractory systemic Anaplastic Large Cell Lymphoma (ALCL) with T or Null phenotype or relapsed or refractory mature T-cell lymphomas. * All patients should have evaluable or measurable disease on entry to study. * Requires systemic therapy * Performance Status Eastern Cooperative Oncology Group (ECOG) less than or equal to 2 * Age 7 years or older * Human immunodeficiency virus (HIV) negative * Patients should not have received systemic cytotoxic chemotherapy within 3 weeks of study entry. Design: * The study will be a Phase II study. * Patients will receive the first cycle of UCN-01 over 72 hours on days 1-3 and subsequent cycles over 36 hours. Patients with stable disease may receive UCN-01 for up to 1 year beyond achieving maximum response or stable disease, and restaging will be done every 2 cycles for the first 6 cycles and every 4 cycles thereafter. * Two sequential biopsies will be performed to investigate complimentary deoxyribonucleic acid (cDNA) expression by microarray. Soluble Tac (CD25) will be serially followed in patients. * For each of the two histologies, this study will be conducted using a Simon two-stage optimal design. Up to 37 patients will be treated.

Titre officielPhase II Study of UCN-01 in Relapsed or Refractory Systemic Anaplastic Large Cell and Mature T-Cell Lymphomas
NCT00082017NCT00085319
Sponsor principalNational Cancer Institute (NCI)
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

20 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 12 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies hématologiques et lymphatiquesMaladies du Système ImmunitaireTroubles immunoprolifératifsLymphomeMaladies lymphatiquesLymphome non hodgkinienTroubles LymphoprolifératifsNéoplasmes par type histologiqueNéoplasmesLymphome à cellules TLymphome anaplasique à grandes cellules

Critères

* INCLUSION CRITERIA: Relapsed or refractory systemic Anaplastic Large Cell Lymphoma (ALCL). Relapsed or refractory mature T-cell lymphoma to include peripheral T-cell lymphoma unspecified and the following "specified" mature T-cell lymphomas: Adult T-cell lymphoma; Extranodal natural killer (NK)/T-cell lymphoma, nasal type; Enteropathy-type T-cell lymphoma; Hepatosplenic T-cell lymphoma; Subcutaneous panniculitis-like T-cell lymphoma; Angioimmunoblastic T-cell lymphoma. All patients should have evaluable or measurable disease on entry to study. Histology confirmed by Laboratory of Pathology, National Cancer Institute (NCI). Performance Status Eastern Cooperative Oncology Group (ECOG) less than or equal to 2. Age 7 years or older. Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 50 ml/min for patients at least 18 years. Pediatric patients should have maximum serum creatinine by age as follows: * Less than age 7 and less than or equal to age 10 may have a Maximum Serum Creatinine of 1.0 mg/dl * Less than age10 and less than or equal to age 15 may have a Maximum Serum Creatinine of 1.2 mg/dl * Age 15 years or older may have a Maximum Serum Creatinine of 1.5 mg/dl Alternatively, pediatric patients should have a creatinine clearance of greater than 50 m1/min/1.73m\^2. Total bilirubin less than 1.5 x upper limit of normal (ULN) (patients with elevation of total bilirubin consistent with Gilbert's disease are eligible providing they have a normal direct bilirubin); aspartate aminotransferase (AST) less than or equal to 2.5 x ULN; absolute neutrophil count (ANC) greater than 500/mm\^3; and platelet greater than or equal to 50,000/mm\^3; unless hematological impairment due to organ involvement by lymphoma. Provides signed informed consent. Not pregnant or nursing. This drug has unknown effects in pregnancy and on young infants/children. Human immunodeficiency virus (HIV) negative. Willing to use contraception and continue for at least 8 weeks following the last treatment. No active central nervous system (CNS) lymphoma. Patients should not have received systemic cytotoxic chemotherapy within 3 weeks of study entry. Have recovered from the toxic effects of prior therapy to a grade less than or equal to 1. No history of diabetes mellitus requiring insulin treatment. No symptomatic pulmonary disease. No evidence of symptomatic cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, exertional angina pectoris, cardiac arrhythmia). Patients may not be concurrently receiving any other investigational agents. Not a candidate for potentially curative (i.e. transplant) treatment at the time of study entry or the patient has a window of opportunity to receive UCN-01 before a transplant. Patients are required to have considered a transplant. If, having done this, they refuse it, decide against it or decide to wait, they would be eligible for this study.

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2 Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 28 days.

Groupe II

Expérimental
Cycle 1: 45 mg/m\^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m\^2 Cycle 2: 45 mg/m\^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m\^2; Repeat cycles every 21 days.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

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National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOuvrir National Institutes of Health Clinical Center, 9000 Rockville Pike dans Google Maps
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