- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01909752
Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer
3. juli 2017 oppdatert av: UbiVac
Randomized Phase II Trial of Cyclophosphamide With Allogeneic Non-Small Cell Lung Cancer (NSCLC) DRibble Vaccine Alone or With Granulocyte-Macrophage Colony-Stimulating Factor or Imiquimod for Adjuvant Treatment of Definitively-Treated Stage IIIA or IIIB NSCLC
This study will test an investigational vaccine, called DRibbles, for the treatment of non-small cell lung cancer (NSCLC).
We hypothesize that vaccination with the DRibble vaccine will cause an immune responses against proteins contained in the DRibble vaccine and the protein antigens targeted by this strong immune response will include common antigens shared by both the vaccine and the patient's tumor.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is an open-label, randomized study in which the first 33 patients will be assigned to receive the either:
- DRibbles vaccine and HPV vaccine
- DRibbles vaccine, HPV vaccine, and imiquimod
- DRibbles vaccine, HPV vaccine, and GM-CSF After 11 patients have been assigned to each group, the study arm with the greatest number of vaccine-induced strong antibody responses will then continue with enrollment of 15 further patients. The primary objective is to determine the best strategy to induce strong (>15 fold) tumor-specific or tumor-associated antibody responses in patients with stage III A and B NSCLC. The goal is to select one regimen to advance to additional clinical trials.
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Louisiana
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New Orleans, Louisiana, Forente stater, 70112
- LSU Stanley S. Scott Cancer Center
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Oregon
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Portland, Oregon, Forente stater, 97213
- Providence Cancer Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Stage IIIA or IIIB histologically proven non-small cell lung cancer
- Completion of definitive therapy
- Enrollment from 28 days to 12 weeks from completion of definitive therapy
- Toxicities from definitive therapy resolved to less than grade 1
- ECOG performance status 0-1
- Negative pregnancy test in women of childbearing potential
- Agree to avoid pregnancy or fathering a child while on study treatment
- Ability to give informed consent and comply with protocol
- Anticipated survival minimum of 6 months
- Prior therapy with investigational agents must be completed at least 3 weeks prior to study enrollment
- Normal organ and marrow function as defined by specific lab tests
- Archived tumor tissue available
Exclusion Criteria:
- Active autoimmune disease except for vitilogo or hypothyroidism
- Active other malignancy
- Known HIV+ and/or Hepatitis B or C positive
- Medical or psychiatric conditions that would preclude safe participation
- Ongoing chemotherapy
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: DRibble Vaccine Alone
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
Immunization with HPV vaccine intramuscular injection at the time of the first and third vaccinations.
|
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
Andre navn:
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
Immunization with HPV vaccine will consist of two 0.5-mL intramuscular injection at the time of the first and third vaccinations.
The preferred site of administration is the deltoid region of the upper arm.
Andre navn:
|
Eksperimentell: DRibble vaccine with imiquimod
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
Imiquimod cream (5%, 250 mg containing 12.5 mg imiquimod - one packet/day) will be self applied once per day starting with the second vaccine (week 4) and for four days following each vaccine cycle.
Immunization with HPV vaccine intramuscular injection at the time of the first and third vaccinations.
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Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
Andre navn:
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
Immunization with HPV vaccine will consist of two 0.5-mL intramuscular injection at the time of the first and third vaccinations.
The preferred site of administration is the deltoid region of the upper arm.
Andre navn:
Imiquimod cream (5%, 250 mg containing 12.5 mg imiquimod - one packet/day) will be self applied once per day starting with the second vaccine (week 4).
Immediately following vaccination and for four days following each vaccine cycle (total 5 days) imiquimod will be applied to a 4 x 5-cm outlined area of healthy extremity skin that includes the vaccine site.
Andre navn:
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Eksperimentell: DRibble vaccine with GM-CSF
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
GM-CSF will be administered at 50 mcg/day starting with the second vaccine (week 4) and continuing with each subsequent vaccine.
Immunization with HPV vaccine intramuscular injection at the time of the first and third vaccinations.
|
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
Andre navn:
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
Immunization with HPV vaccine will consist of two 0.5-mL intramuscular injection at the time of the first and third vaccinations.
The preferred site of administration is the deltoid region of the upper arm.
Andre navn:
GM-CSF will be administered at 50 mcg/day starting with the second vaccine (week 4) and continuing with each subsequent vaccine.
A volume of 0.2 cc will be delivered by the CADD-MSTM 3 Ambulatory infusion pump at a rate of 0.008 cc/hr.
The pump will be refilled after three days for a total of six days of infusion.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Identify the regimen that produces the strongest antibody response
Tidsramme: 95 days
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The best regimen will be defined as the one that generates the greatest increase in the number of strong antibody responses as defined by a greater than 15-fold increase in antibody, as measured using the Immune Response Biomarker Profiling Array (Invitrogen) on the day 95 serum sample.
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95 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Safety
Tidsramme: 43 weeks
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To evaluate the overall safety of allogeneic NSCLC DRibble vaccine alone or in combination with either imiquimod or GM-CSF, as adjuvant treatment for definitively-treated patients with Stage IIIA or B NSCLC.
During the treatment period, patients will be seen in clinic 13 times over a 22-week period; performance status and side-effects will be evaluated at each visit.
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43 weeks
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Progresjonsfri overlevelse
Tidsramme: 2 år
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Evaluer progresjonsfri overlevelse.
Tumormålinger ved CT-skanning vil bli tatt i uke 16 og deretter etter den behandlende utrederens skjønn.
Etter behandlingsperioden vil pasientene sees hver 3. måned i 2 år, eller frem til progredierende sykdom.
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2 år
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Immune response and progression-free survival correlation.
Tidsramme: 2 years
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Evaluate whether any immune response data correlate with progression-free survival.
Immune response data will be collected 12 times over the first 43 weeks and then every 3 months until two years or progressive disease.
This data will be correlated with progression-free survival.
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2 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Bernard Fox, PhD, UbiVac
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2013
Primær fullføring (Faktiske)
1. november 2016
Studiet fullført (Faktiske)
1. april 2017
Datoer for studieregistrering
Først innsendt
24. juli 2013
Først innsendt som oppfylte QC-kriteriene
24. juli 2013
Først lagt ut (Anslag)
26. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. juli 2017
Sist bekreftet
1. juli 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Adjuvanser, immunologiske
- Interferon-indusere
- Cyklofosfamid
- Vaksiner
- Imiquimod
Andre studie-ID-numre
- UbiVac DPV-001
- R44CA121612 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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