Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Intratumoral Dendritic Cell Vaccination Combined With Local Radiotherapy in Patients With Recurrent Lymphoma.

9. juni 2017 oppdatert av: Baylor Research Institute

A Phase I/II Study of Intratumoral Dendritic Cell Vaccination Combined With Local Radiotherapy in Patients With Recurrent Lymphoma.

The purpose of the study is to gather data on feasibility and on immune and clinical efficacy of intratumoral dendritic cell (DC) vaccination in combination with local radiotherapy in patients with recurrent lymphoma

Studieoversikt

Detaljert beskrivelse

Lymphoma is extremely sensitive to radiation and is a commonly used therapy. The major issue in application of local radiotherapy is the relative short duration of response and as a consequence is used mainly for palliation. Therefore novel therapies are needed to improve the outcome of patients with lymphomas. The potential specificity of the immune system to recognize and eliminate tumor cells is especially relevant in lymphoma. Immune responses are induced, coordinated and regulated by dendritic cells (DCs), the most potent antigen-presenting cells. Based on the central role of DCs in initiating immune responses, four vaccinations will be administered at intervals beginning two days after low dose radiation is given to the tumor site.

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Biopsy confirmed recurrent lymphoma of any initial stage, either Hodgkin's lymphoma or the B cell or T cell NHL of an indolent nature. For B cell lymphoma, follicular lymphoma, small lymphocytic lymphoma, marginal zone lymphoma, and those indolent patients with mantle cell lymphoma or diffuse large B cell lymphoma will be included. For T cell lymphoma, the patients with indolent cutaneous T cell lymphomas (mycosis fungoides or primary cutaneous anaplastic large cell lymphoma) who have failed or have been intolerant of one systemic or two topical treatments will be included.
  • Patients must have failed at least one line of prior treatment but not more than four (including autologous but not allogeneic stem cell transplant).
  • Patients must have at least one site of disease that is accessible for intratumoral injection of DCs percutaneously after palliative local radiotherapy
  • Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the treatment.
  • Patients must have measurable disease other than the injection site or biopsy site.
  • 18 years of age or older.
  • Karnofsky Performance Status (KPS) of > 70.
  • Adequate bone marrow function: WBC >2000/uL, platelet count >75,000/mm3; ANC>1000.
  • Adequate hepatic function: bilirubin <= 1.5 mg/dL; SGOT/SGPT<2.5x upper limit of normal
  • Adequate renal function: serum creatinine <= 2.0mg/dL.
  • Required wash out periods for prior therapy:
  • Topical therapy: 2 weeks
  • Chemotherapy: 4 weeks (12 weeks for purine analogs)
  • Radiotherapy (including photo therapy): 4 weeks
  • Other systemic biological therapy: 4 weeks
  • Other investigational therapy: 4 weeks
  • Patients of reproductive potential and their partners must agree to use an effective (>90% reliability) form of contraception during the study and for 4 weeks following the last study drug administration.
  • Women of reproductive potential must have negative urine pregnancy test.
  • Life expectancy greater than 4 months.
  • Able to comply with the treatment schedule.

Exclusion Criteria:

  • Pre-existing autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, etc, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease.
  • Known history of human immunodeficiency virus (HIV) or hepatitis B or C.
  • CNS metastases
  • Prior malignancy (active within 5 years of screening) except basal cell or completely excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix.
  • Current anticoagulant therapy (ASA<= 325 mg/day allowed).
  • Significant cardiovascular disease (i.e., NYHA class 3 congestive heart failure; myocardial infarction with the past 6 months; unstable angina; coronary angioplasty with the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
  • Pregnant or lactating.
  • Prior therapy with allogeneic stem cell transplant.
  • Any other medical history, including laboratory results, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the results.

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Safety and feasibility of intratumoral dendritic cell vaccination
Tidsramme: 2 years
2 years

Sekundære resultatmål

Resultatmål
Tidsramme
Clinical activity-response in local and distant lesions
Tidsramme: 2 years
2 years
Immunological response with conventional CTL assay, proliferation assay and microarray-based immune gene profiling using peripheral blood and/or biopsied tumor
Tidsramme: 2 years
2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Karolina Palucka, MD, PhD

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 2008

Primær fullføring (Forventet)

1. mars 2010

Studiet fullført (Forventet)

1. mars 2010

Datoer for studieregistrering

Først innsendt

10. mars 2008

Først innsendt som oppfylte QC-kriteriene

14. mars 2008

Først lagt ut (Anslag)

17. mars 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. juni 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

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. .

Abonnere