NU-0129 Spherical Nucleic Acid Gold Nanoparticle for Recurrent Glioblastoma Multiforme or Gliosarcoma
Laboratory Biomarker Analysis
+ Pharmacological Study
+ Targeted Molecular Therapy
Astrocytome+8
+ Glioblastome
+ Gliome
Étude thérapeutique
Résumé
Date de début de l'étude : 25 mai 2017
Date à laquelle le premier participant a commencé l'étude.This is a study about a new treatment called NU-0129 for patients with recurrent glioblastoma multiforme (GBM) or gliosarcoma (GS), which are types of brain tumors. The main goal is to see if it's safe to give NU-0129 through a vein (intravenously). The study is important because it's the first time this treatment is being tested in humans, and it could potentially help improve care for people with these types of brain tumors. During the study, participants will receive NU-0129 through an IV for 20-50 minutes. Then, they will have a standard tumor removal surgery within 8-48 hours. After the treatment, participants will be checked on at 7, 14, 21, and 28 days, and then every 84 days for up to 2 years. The study will look at any side effects, how much of the drug is in the blood at different times, if the drug reaches the tumor, and if it's feasible to give this treatment as a standard care. It will also check the tumor tissue for changes after the drug is given and see how patients respond to the treatment in terms of survival and tumor shrinkage.
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.8 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 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
Critères
Inclusion Criteria: * Patients must have histologically proven glioblastoma multiforme (GBM) or gliosarcoma (GS) * Patients must have measurable disease by Response Assessment in Neuro-Oncology (RANO) 2010 criteria at the time of registration (pre-operative) * Patients must have failed at least one regimen of chemo or radiation therapy; NOTE: There is no limit to the number or types of prior therapy * The patient must be a candidate for surgical debulking (either subtotal or gross total resection); biopsy-only candidates will not be eligible * All patients must be capable to voluntarily sign an informed consent indicating that they are aware of the investigational nature of this study prior to registration * Patients must have a Karnofsky performance status of \>= 70 * Patients must have adequate bone marrow, liver, coagulation and renal function within 7days prior to study registration, as defined below: * White blood cell count (WBC) \>= 3,000/uL * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count of \>= 100,000/mm\^3 (Note: Transfusion or growth factor may be used for eligibility outside of 7 days) * Hemoglobin \>= 8 mg/dL (Note: Transfusion may be used for eligibility outside of 7 days) * Bilirubin =\< 2 x upper limit of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2 x ULN * Creatinine =\< 1.5 x ULN * Urine protein =\< 3 x ULN * Cholesterol =\< 300 mg/dL * International normalized ration (INR) =\< 1.5 x ULN * Prothrombin time (PT)/partial thromboplastin time (PTT) =\< 1.5 x ULN * Any patient who has had a recent surgery should have recovered from all effects of the surgery and be cleared by their surgeon * Patients must have confirmed availability of archival or freshly biopsied tumor tissue meeting protocol-defined specifications (10 unstained slides) prior to study enrollment * Females of child-bearing potential (FOCBP) and males must agree to use adequate contraception (e.g. hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 28 days following completion of therapy; should a female patient, or a male patient's partner, become pregnant or suspect she is pregnant while participating in this study, the patient should inform her or his treating physician immediately * NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months) * FOCBP must have a negative pregnancy test (either urine or serum) within 14 days prior to registration Exclusion Criteria: * Patients must not have any significant infections or medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate NU-0129 * Patients must not have a history of any other cancer unless they are in complete remission and off of all therapy for that disease for a minimum of 3 years * Note: Non-melanoma skin cancer or carcinoma in-situ of the cervix are exceptions and may be permitted after discussion with study quality assurance manager (QAM) * Patients must not have had radiation therapy within 12 weeks prior to registration * Patients must not have had prior cancer therapy (including biologic, cytotoxic, and experimental therapies, nitrosoureas, and Gliadel wafers or other surgically implantable antitumor treatment) within 21 days of registration; if questions arise, please ask the principal investigator (PI) * NOTE: Patients must not have Novocure within 24 hours * Hormonal tumor therapies should not be administered within 14 days of registration; exceptions may be discussed with the PI * Patients must not have symptomatic hypertension * Patients with known human immunodeficiency virus (HIV) infection or chronic or acute hepatitis B or C are not eligible; Note: Patients do not need to have HIV, hepatitis B, or hepatitis C testing at screening * Female patients who are pregnant or breast feeding are not eligible * Patients are not eligible if they are unwilling or unable to comply with the protocol
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs 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