- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02419170
Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)
Studieoversigt
Status
Detaljeret beskrivelse
Undersøgelsestype
Fase
- Tidlig fase 1
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with completely resected stage I non-small cell lung cancer who are not considered for adjuvant post operative therapy.
- Age ≥ 18 years.
- ECOG performance status 0-1.
- HLA-A2 positive.
Required initial laboratory values (submitted within 14 days prior to registration):
- WBC > 3,000/mm3
- Hg ≥ 9.0 gm/dL
- Platelets >75,000/mm3
- Serum bilirubin < 2.0 mg/dL
- Serum creatinine < 2.0 mg/dL
- Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy.
- Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria:
- Prior treatment with cytotoxic chemotherapy
- Prior treatment with targeted therapy or immunotherapy.
- Active untreated CNS metastasis.
- Active infection.
- Prior malignancy (except non-melanoma skin cancer) within 3 years.
- Pregnant or nursing.
- Concurrent treatment with systemic corticosteroids; local (inhaled or topical) steroids are permitted.
- Known allergy to eggs.
- Prior history or uveitis or autoimmune inflammatory eye disease.
- Known positivity for hepatitis B sAg, hepatitis C antibody, or HIV antibody.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Surgery/Apheresis/Cyclophosphamide/Vaccine
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Immunological response as measured by increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay
Tidsramme: 1 year
|
-Blood for immunological response is drawn every week from Dose #1 to 6 weeks after Dose #3 (Day 1 to Day 126 = Week 18 and then every 4 weeks until Day 365)
|
1 year
|
Safety and tolerability of vaccine as measured by adverse events experienced and graded by NCI CTCAE Version 4.0
Tidsramme: 30 days after last vaccine (approximately Day 115)
|
Safety will be closely monitored after vaccination. Patients will be observed for 2 hours after the first dose and vital signs recorded every 30 minutes during that time period beginning at the start of the infusion. For each dose thereafter, patients will be observed in the treatment area for 30 minutes after the infusion. The following parameters will be assessed:
|
30 days after last vaccine (approximately Day 115)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Time to progression (TTP)
Tidsramme: 5 years
|
These patients have been completed resected so there is no tumor response to monitor.
CT scans evaluating for progression will be performed at baseline, following the third vaccine dose, and as per routine care during follow-up (generally every 3 months for the first year and every 6 months for the next 4 years thereafter).
|
5 years
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antirheumatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Cyclofosfamid
Andre undersøgelses-id-numre
- 15-x043
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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