- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00319748
Study of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers
21 août 2019 mis à jour par: Masonic Cancer Center, University of Minnesota
Phase II Study of 852A Administered Subcutaneously in Patients With Metastatic Refractory Breast, Ovarian, Endometrial and Cervical Cancers
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat metastatic breast, ovarian, endometrial or cervical cancer not responding to standard treatment.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Description détaillée
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability.
Type d'étude
Interventionnel
Inscription (Réel)
15
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- Masonic Cancer Center, University of Minnesota
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
Adequate performance status:
- Breast - Karnofsky score > 50;
- Ovarian, endometrial or cervical - Gynecologic Oncology Group (GOG) performance score ≤2
- If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation.
- Normal organ function within 14 days of study entry
Diagnosis of one of the following malignancies:
- Metastatic breast cancer (BR)
- Metastatic ovarian cancer (OV)
- Metastatic endometrial cancer (EM)
- Metastatic cervical cancer (CX)
Breast Cancer Inclusion Criteria:
- Measurable metastatic disease (>1cm) in at least one site other than bone-only
- Progression on or failure to respond to at least one previous chemotherapy regimen for metastatic disease
- Progression on prior therapy with a hormonal agent if estrogen receptor or progesterone receptor positive, and/or with trastuzumab if HER2-neu positive. If patient has progressed through hormone or trastuzumab therapy only, must have received one chemotherapy regimen.
Ovarian Cancer Inclusion Criteria:
- Measurable metastatic disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- Primary tumor must have been diagnosed histologically as either epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (not borderline or low malignant potential epithelial carcinoma).
- Subjects must have failed at least two previous chemotherapy regimens. Paclitaxel must have been a component of one or both regimens and cisplatin or carboplatin must have been a component of one or both regimens.
Endometrial Cancer Inclusion Criteria:
- Measurable metastatic disease
- Histologically proven recurrent or persistent endometrial cancer that is not amenable to curative treatment with surgery and/or radiation therapy AND has failed 2 previous treatment regimens
Cervical Cancer Inclusion Criteria:
- Measurable metastatic disease
- Histologically proven recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy AND has failed 2 previous treatment regimens.
Exclusion Criteria:
Had/have the following prior/concurrent therapy:
- Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)
- Investigational drugs/agents within 14 days of first dose of 852A
- Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose)
- Drugs known to induce QT interval prolongation and/or induce Torsades de pointes unless best available drug required to treat life-threatening conditions
- Radiotherapy within 3 weeks of the first dose of 852A
- Hematopoietic cell transplantation within 4 weeks of first dose of 852A
- Evidence of active infection within 3 days of first dose of 852A
- Active fungal infection or pulmonary infiltrates (prior treated disease stable for 2 weeks is allowable)
- Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication
- History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
- Uncontrolled intercurrent or chronic illness
- Active autoimmune disease requiring immunosuppressive therapy within 30 days
- Active coagulation disorder not controlled with medication
- Pregnant or lactating
- Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas that have been adequately treated
- Any history of brain metastases or any other active central nervous system (CNS) disease
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Intent-To-Treat
Patients treated with at least one dose - 852A subcutaneous injection.
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0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.
Autres noms:
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Expérimental: Evaluable Cohort
Patients who received all 24 doses of 852A per protocol.
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0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.
Délai: after 12 weeks (24 doses of 852A)
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Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses.
Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.
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after 12 weeks (24 doses of 852A)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)
Délai: Prior to Dose 1 and 6 hours after Dose 1
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Measures the difference of IL1ra (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
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Prior to Dose 1 and 6 hours after Dose 1
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Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)
Délai: Prior to Dose 1 and 6 Hours Post-Dose
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Measures differences in IP-10 (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
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Prior to Dose 1 and 6 Hours Post-Dose
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Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)
Délai: Prior to Dose 1 and 6 Hours Post-Dose
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Measures difference in MIP-1a (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
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Prior to Dose 1 and 6 Hours Post-Dose
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Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)
Délai: Prior to Dose 1 and 6 Hours Post-Dose
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Measures difference in Macrophage Inflammatory Protein-1 Beta (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
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Prior to Dose 1 and 6 Hours Post-Dose
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Mean Difference Values for Soluble CD40 Ligand (sCD40L)
Délai: Prior to Dose 1 and 6 Hours Post-Dose
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Measures difference in Soluble CD40 ligand (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
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Prior to Dose 1 and 6 Hours Post-Dose
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Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a)
Délai: Prior to Dose 1 and 6 Hours Post-Dose
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Measures difference in Tumor necrosis factor-alpha (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
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Prior to Dose 1 and 6 Hours Post-Dose
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Sarah Cooley, MD, Masonic Cancer Center, University of Minnesota
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2006
Achèvement primaire (Réel)
1 décembre 2007
Achèvement de l'étude (Réel)
1 décembre 2008
Dates d'inscription aux études
Première soumission
27 avril 2006
Première soumission répondant aux critères de contrôle qualité
27 avril 2006
Première publication (Estimation)
27 avril 2006
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 août 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 août 2019
Dernière vérification
1 août 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs utérines
- Tumeurs génitales, femme
- Maladies du col de l'utérus
- Maladies utérines
- Maladies du système endocrinien
- Maladies ovariennes
- Maladies annexielles
- Troubles gonadiques
- Tumeurs des glandes endocrines
- Tumeurs du col de l'utérus
- Tumeurs ovariennes
- Tumeurs de l'endomètre
Autres numéros d'identification d'étude
- 06US03IMP-852A
- MT2006-02 (Autre identifiant: Blood and Bone Marrow Transplantation Program)
- 2006LS005 (Autre identifiant: Masonic Cancer Center, University of Minnesota)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Cancer du col de l'utérus
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Imperial College Healthcare NHS TrustImperial College London; The Wellington Hospital, LondonComplété
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Duke UniversityNational Cancer Institute (NCI); Jacobi Medical CenterComplété
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Michigan State UniversityAmerican Osteopathic AssociationComplété
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Duke UniversityUniversity of ArkansasComplété
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New York Institute of TechnologyComplété
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Michigan State UniversityComplété
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NuVasiveActif, ne recrute pasTrouble discal dégénératif cervicalÉtats-Unis
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Goethe UniversityComplétéCinématique | Fiabilité | CervicalAllemagne
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Xin Jiang, MDInconnueBloc du plexus cervical superficielChine
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National Cancer Institute (NCI)ComplétéPoumon | Sein | Ovaire | Cervical | RénalÉtats-Unis
Essais cliniques sur 852A
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Rogers, B.H. Gerald, M.D.3MRésiliéOesophage de BarrettÉtats-Unis
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PfizerComplétéMélanome | Unresectable Metatstatic Cutaneous MelanomaSuisse, Allemagne, France
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Masonic Cancer Center, University of MinnesotaPfizerComplété
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PfizerComplété