- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00576446
Surgical Resection With Gliadel Wafer Followed by Dendritic Cells Vaccination for Malignant Glioma Patients (Gliadel Wafer)
A Phase l Trial of Surgical Resection With Gliadel Wafer Placement Followed by Vaccination With Dendritic Cells Pulsed With Tumor Lysate for Patients With Malignant Glioma
Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis carries with it a median survival of approximately 12 months, with 90 - 95% of patients surviving less than 2 years. The current standard treatment of surgical resection followed by radiation therapy and chemotherapy has not substantially prolonged survival and even the few treatment options shown to exhibit small increases in survival primarily benefit certain (i.e., young) patient subpopulations.
Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body to recognize the tumor cells as foreign and produce its own response to fight off recurring tumor cells. A promising means of causing an immune response so the body can create this immunity is through the use of dendritic cell (DC) vaccines.
Dendritic cells are a small group of cells contained in everyone's white blood cell population. These cells are responsible for letting the immune system know that something foreign, like bacteria, or a tumor, is in the body. Dendritic cells help the body ward off disease by alerting the immune system.
gliadel is an FDA - approved drug - a wafer containing a concentrated amount of a chemotherapy agent. These wafers are placed into the brain cavity after the tumor is resected (removed) and deliver a steady amount of immediate chemotherapy medicine to the surrounding brain tissue. Also, since Gliadel is a local chemotherapy, it will prevent the detrimental suppression (weakening) of the immune system shown with systemic (throughout the body) chemotherapy.
In prior Phase l and phase ll studies, patients who received chemotherapy following Dendritic cells demonstrated longer progression free and overall survival than the patients who received Dendritic cells or chemotherapy alone.
The purpose of this study is to determine whether after standard therapy of tumor resection surgery, along with placement of Gliadel wafers at time of surgery followed by dendritic cell vaccines will not only generate (start) an immune response, but will provide longer progression free survival.
Patients who were screened and not enrolled in this clinical trial due to screen failure will be notified of the reason for screen failure. Pre HIV counseling and appropriate referral resources will be provided. If the screen failure is due to the positive HIV test, appropriate post HIV counseling will be provided and appropriate referrals will be made. The charts of the patients with screen failures will be destroyed.The patients charts who will be enrolled in the study kept in the locked cabinet in the research office. patients will be assigned a unique identifying code known only to the research team. Data will be captured by various source documents, or, as necessary, abstracted from hospital medical records by an experienced registered nurse. The electronic data for viral testing will be accessible to research personnel only.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
California
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Los Angeles, California, Förenta staterna, 90048
- Cedars Sinai Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients must have a histopathological diagnosis of malignant glioma
- Patients must have undergone surgery and placement of Gliadel wafer.
- Women of child bearing potential must use medically accepted form of birth control.
- A Karnofsky performance status of at least 60%
- Must be off of steroid at least two weeks prior to vaccination
- Hematologic and metabolic panel results will be within the parameters of the protocol.
- Must be capable of IRB approved Informed Consent.
Exclusion Criteria:
- Patients with systemic disease
- Presence of acute infection
- Contraindication to MRI
- Known history of autoimmune disorder
- Pregnancy
- Positive for hepatitis B, C, HIV, syphilis, HTLVa nd HCV
- Allergic to Gentamicin.
- Inability to participate as per Principal Investigator's discretion.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
|
Patients will receive three vaccines every two weeks
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
To assess the survival of malignant glioma a, to assess the immunogeneicity of patients who receive Dendritic cell vaccine , to assess progression free survival and to evaluate quality of life.
Tidsram: 1 year
|
1 year
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 9789
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Kliniska prövningar på Malignt gliom
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Children's Hospital of PhiladelphiaBlue Earth Diagnostics, Inc; Dragon Master FoundationRekryteringGliom | Höggradig Gliom | Gliom, elakartad | Diffus gliom | Gliom intrakranielltFörenta staterna
-
Children's Hospital of PhiladelphiaBlue Earth Diagnostics; Dragon Master FoundationHar inte rekryterat ännuGliom | Låggradigt Gliom | Gliom, elakartad | Låggradigt gliom i hjärnan | Gliom intrakranielltFörenta staterna
-
City of Hope Medical CenterNational Cancer Institute (NCI); Food and Drug Administration (FDA)Aktiv, inte rekryterandeÅterkommande glioblastom | Återkommande malignt gliom | Refraktärt malignt gliom | Återkommande WHO Grad III Gliom | Återkommande WHO Grad II Gliom | Refraktär glioblastom | Refraktär WHO Grade II Gliom | Refraktär WHO Grad III GliomFörenta staterna
-
University of California, San FranciscoBeiGene USA, Inc.; Pacific Pediatric Neuro-Oncology ConsortiumRekryteringGlioblastom | Malignt gliom | Återkommande glioblastom | Återkommande WHO Grad III Gliom | WHO Grad III Gliom | IDH2-genmutation | IDH1-genmutation | Låggradig gliom | Återkommande WHO Grad II Gliom | WHO Grad II GliomFörenta staterna
-
Beijing Tiantan HospitalDuke UniversityOkändGlioblastom | Höggradig Gliom | Gliom, elakartad | Gliom av hjärnstammenKina
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National Cancer Institute (NCI)RekryteringGliom | Höggradig Gliom | Malignt gliom | Gliomas | Låggradig gliomFörenta staterna
-
ChimerixAktiv, inte rekryterandeGlioblastom | Diffus mittlinjegliom | H3 K27M Gliom | Thalamisk gliom | Infratentoriellt gliom | Basal Ganglia GliomFörenta staterna
-
City of Hope Medical CenterNational Cancer Institute (NCI)Aktiv, inte rekryterandeGlioblastom | Malignt gliom | WHO Grad III Gliom | Återkommande Gliom | Eldfast GliomFörenta staterna
-
Hospital del Río HortegaAvslutadGliom | Glioblastom | Låggradigt Gliom | Gliom, elakartad | Högkvalitativ GliomSpanien
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SanofiAvslutadGlioblastoma Multiforme | Maligna gliom | Blandade gliomFörenta staterna
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