- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00058019
Ixabepilone in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
A Phase II Study of Epothilone B Analog BMS-247550 (NSC 710428) in Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
I. Determine the objective overall response rate of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma treated with BMS-247550 (ixabepilone).
II. Determine the safety and toxicity of this drug in these patients. III. Determine the duration of response, overall survival, and time to progression in patients treated with this drug.
OUTLINE: This is a multi-center study.
Patients receive ixabepilone intravenously (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.
Patients are followed every 8 weeks until disease progression.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60637
- University of Chicago
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Texas
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Houston, Texas, États-Unis, 77030
- M D Anderson Cancer Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following cellular types:
- Grade III follicular center
- Diffuse large B-cell
- Mantle cell
- Primary mediastinal B-cell
- Burkitt's
- High-grade B-cell (Burkitt-like)
Anaplastic large cell of 1 of the following subtypes:
- CD30-positive
- T-cell
- Null cell
- Hodgkin's-like
Relapsed or refractory disease after prior standard chemotherapy, meeting criteria for 1of the following cohorts:
- Cohort 1 (relapsed but chemosensitive): Prior complete response (CR) or partial response (PR) lasting at least 4 weeks after the most recent prior therapy
Cohort 2 (refractory): Stable disease or less than a PR after the most recent prior therapy
- No progressive disease after the most recent prior therapy
Measurable disease
- At least 1 bidimensionally measurable lesion at least 10 mm by conventional techniques or clinical exam
Ineligible for or unwilling to undergo hematopoietic stem cell transplantation
- Patients requiring debulking prior to transplant allowed
No known CNS involvement by lymphoma
- Prior CNS disease that has been successfully treated in patients with relapsed disease exclusively outside of the CNS may be allowed by the principal investigator
- Performance status - ECOG 0-2
- More than 3 months
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,200/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- AST/ALT no greater than 2.5 times upper limit of normal
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reaction or hypersensitivity to compounds containing Cremophor EL or agents of similar chemical or biological composition to BMS-247550
- No peripheral neuropathy grade 2 or greater
- No other currently active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix (previously treated malignancy allowed if considered to be at less than 30% risk of relapse)
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent uncontrolled illness
- No colony-stimulating factors (CSFs) within 24 hours of study chemotherapy
- No CSFs during first course of study therapy
- No concurrent filgrastim-SD/01
- No concurrent immunotherapy
- See Disease Characteristics
- At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No other concurrent chemotherapy
- No concurrent hormonal therapy
- At least 4 weeks since prior radiotherapy
- No concurrent therapeutic radiotherapy
- At least 4 weeks since prior surgery
- Recovered from prior therapy
- At least 7 days since prior cimetidine
- No concurrent cimetidine
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer medications
- No concurrent unconventional therapies, food, or vitamin supplements containing Hypericum perforatum
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Treatment (chemotherapy)
Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15.
Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.
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Étant donné IV
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Objective Overall Response Rate
Délai: up to 3 years
|
The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10561185) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment.
CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.
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up to 3 years
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Safety and Toxicity of Ixabepilone
Délai: up to 3 years
|
Number of patients experiencing adverse event grade 3 or above.
Grade was determined by the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0.
Adverse events possibly, probably, or definitely attributed to use of ixabepilone.
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up to 3 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Duration of Response
Délai: up to 3 years
|
Duration of response was measured from the time measurement criteria are met for CR(complete response)/CRu(unconfirmed complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented.
According to the 1999 international response criteria as published by Cheson, CR/CRu is defined as the disappearance of all target lesions; PR is defined as >=50% decrease in the sum of the products of the greatest diameters; PD is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.
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up to 3 years
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Overall Survival
Délai: up to 3 years
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Defined as the time from the first day of therapy to the date of death.
If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.
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up to 3 years
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Time to Progression
Délai: up to 3 years
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Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported.
Patients who died without a reported prior progression was considered to have progressed on the day of their death.
Patients who did not progress was censored at the day of their last tumor assessment.
According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.
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up to 3 years
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies virales
- Infections
- Maladies du système immunitaire
- Tumeurs par type histologique
- Tumeurs
- Troubles lymphoprolifératifs
- Maladies lymphatiques
- Troubles immunoprolifératifs
- Attributs de la maladie
- Infections par le virus de l'ADN
- Infections virales tumorales
- Infections par le virus Epstein-Barr
- Infections à Herpesviridae
- Lymphome à cellules B
- Lymphome à cellules T
- Lymphome
- Lymphome diffus à grandes cellules B
- Récurrence
- Lymphome non hodgkinien
- Lymphome de Burkitt
- Lymphome à cellules du manteau
- Lymphome anaplasique à grandes cellules
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Épothilones
- Épothilone B
Autres numéros d'identification d'étude
- NCI-2009-00031 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- N01CM62201 (Subvention/contrat des NIH des États-Unis)
- N01CM62202 (Subvention/contrat des NIH des États-Unis)
- P30CA014599 (Subvention/contrat des NIH des États-Unis)
- NCI-5913
- UCCRC-NCI-5913
- CDR0000285683
- UCCRC-11965B
- 11965B (Autre identifiant: University of Chicago)
- 5913 (CTEP)
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