- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00504322
Efficacy Study on the Transfer of Adenovirus With the CD40 Ligand Gene (AdcuCD40L) to Patients With Esophageal Carcinoma (cd40)
3. mai 2016 oppdatert av: Weill Medical College of Cornell University
Phase II, Randomized, Double-blinded, Placebo-Control, Toxicity/Efficacy Study on the Transfer of Adenovirus With the CD40 Ligand Gene (AdcuCD40L) to Patients With Stage I, II or III Esophageal Carcinoma
This study is a randomized, double-blinded assessment of biologic efficacy of AdcuCD40L.
The individuals enrolled in this study will be individuals with biopsy proven resectable esophageal carcinoma.
The dose of the AdcuCD40L vector (administered endoscopically directly to the tumor) will be the highest tolerable dose (most likely 10^11 particle units) determined from Weill-IRB protocol #0011004683 dose escalation study.
Studieoversikt
Status
Tilbaketrukket
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study is designed to add to the safety profile data as well as assessing biologic efficacy parameters.
It will include 24 individuals with biopsy proven, resectable, stage I-III esophageal cancer.
Because there may be immune responses attributable to the gene therapy vector itself, independent of the CD40L transgene, this part of the study is designed in a randomized, blinded fashion to compare intratumoral administration of the AdcuCD40L vector compared to a placebo.
Because there are likely differences over time in the pattern of the biologic response to the expression of CD40L in the tumor (including activation and trafficking of DC, and recruitment and activation of immune cells), this study will include 2 "time" cohorts (based on the time between administration of the AdcuCD40L vector and the time of surgery to remove the tumor).
Using Weill-IRB protocol #0011004683 dose escalation study to determine the highest non-toxic dose of the AdcuCD40L vector, this dose (likely 10^11 particle units) will be used for all individuals enrolled in this efficacy study.
The placebo will be the salt water-sugar solution used as a vehicle for the vector.
Since there is no evidence that delay of surgery for solid tumors for 15 days following diagnosis alters the prognosis, surgery for removal of the primary tumor will be carried out at either 5 or 15 days after administration of the vector (n= 12/group, including n=6 receiving the AdcuCD40L vector, and n=6 receiving placebo).
This will permit assessment of the resulting data (in a randomized, blinded fashion) and the biologic responses to the AdCUCD40L vector over time.
In addition to safety/toxicity parameters, the primary tumor, regional and distant nodes removed at the time of surgery, and peripheral blood will be assessed for biologic parameters relevant to responses to the AdcuCD40L vector.
Studietype
Intervensjonell
Fase
- Fase 2
- Fase 1
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 til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Must be capable of providing informed consent
- Males and females, age 18 to 75 years
- Hematocrit > 30%
- WBC < 10,000
- Normal prothrombin, partial thromboplastin time; platelet count > 100,000
- Normal liver-related serum parameters
- Blood urea nitrogen < 60 mg/dL, creatinine < 2.5 mg/dl
- No evidence of active infection of any type, including with adenovirus, hepatitis virus (A, B or C), or human immunodeficiency virus
- No evidence of central nervous system, major psychiatric, musculoskeletal, or immune disorder
- No allergy to the vehicle used to suspend the virus or contrast materials used in radiographic procedures
- Fertile or infertile individuals; it will be recommended that fertile individuals utilize barrier birth control measures to prevent pregnancy during and for 1 month following the administration of the vector
- Biopsy proven esophageal cancer; clinically stage I-III, deemed resectable by the patient's surgeon. No history of neoadjuvant chemotherapy or chemoradiotherapy. Distant metastases are to be ruled out at the discretion of the physician treating the patient according to standards of care
- Individuals not receiving experimental medications or participating in another experimental protocol for at least 4 weeks prior to entry to the study
- The study individual must be able to undergo the procedures in the protocol
- Willingness to participate in the study
Exclusion Criteria:
- Individuals who do not meet the inclusion criteria will be unable to participate in the protocol
- Individuals in whom participation in the study would compromise the normal care and expected progression of their disease
- Individuals receiving corticosteroids or other immunosuppressive medications; previous splenectomy or radiation to the spleen; autoimmune disease
- Recent (less than 6 week) cerebral vascular accident
- Recent (less than 6 week) transmural myocardial infarction
- Evidence of infection defined by elevated white blood cell count, temperature > 38.5oC or infiltrate on chest x-ray
- Cervical esophageal cancer
- Gastric cancer (tumor more than 50% in the stomach as determined by endoscopy)
- Pathology other than squamous cell or adenocarcinoma
- Malignant ventricular arrhythmia
- Pregnancy
- Immunodeficiency disease, including evidence of HIV infection
- Current alcohol or drug abuse
- Esophageal tumor too small for adequate tissue harvest (determined during esophagoscopy at the time of vector or placebo injection)
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: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: placebo
The placebo will be the salt water-sugar solution used as a vehicle for the vector.
|
The placebo will be the salt water-sugar solution used as a vehicle for the vector.
Andre navn:
|
Aktiv komparator: AdcuCD40L
Using Weill-IRB protocol #0011004683 dose escalation study to determine the highest non-toxic dose of the AdcuCD40L vector, this dose (likely 10^11 particle units) will be used for all individuals enrolled in this efficacy study.
Since there is no evidence that delay of surgery for solid tumors for 15 days following diagnosis alters the prognosis, surgery for removal of the primary tumor will be carried out at either 5 or 15 days after administration of the vector (n= 12/group, including n=6 receiving the AdcuCD40L vector, and n=6 receiving placebo).
This will permit assessment of the resulting data (in a randomized, blinded fashion) and the biologic responses to the AdCUCD40L vector over time.
|
Using Weill-IRB protocol #0011004683 dose escalation study to determine the highest non-toxic dose of the AdcuCD40L vector, this dose (likely 10^11 particle units) will be used for all individuals enrolled in this efficacy study.
Since there is no evidence that delay of surgery for solid tumors for 15 days following diagnosis alters the prognosis, surgery for removal of the primary tumor will be carried out at either 5 or 15 days after administration of the vector (n= 12/group, including n=6 receiving the AdcuCD40L vector, and n=6 receiving placebo).
This will permit assessment of the resulting data (in a randomized, blinded fashion) and the biologic responses to the AdCUCD40L vector over time.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Expression of CD40L and cytokines
Tidsramme: 5-15 days
|
5-15 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Ronald G. Crystal, MD, Department of Genetic Medicine
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 2011
Primær fullføring (Faktiske)
1. juli 2011
Studiet fullført (Faktiske)
1. juli 2011
Datoer for studieregistrering
Først innsendt
19. juli 2007
Først innsendt som oppfylte QC-kriteriene
19. juli 2007
Først lagt ut (Anslag)
20. juli 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. mai 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. mai 2016
Sist bekreftet
1. mai 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0502007770
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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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