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Vaccine Therapy in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer Who Have Finished First-Line Chemotherapy

14 settembre 2017 aggiornato da: University of Miami

Phase I/II Clinical Trial of Immunotherapy With an Allogeneic B7.1/HLA-A1 Transfected Tumor Cell Vaccine in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer That Have Completed First Line Chemotherapy

RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with stage IIIB or stage IV non-small cell lung cancer who have finished first-line chemotherapy.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OUTLINE: This is a multicenter study.

  • Phase I (single site [University of Miami Sylvester Comprehensive Cancer Center]): Patients receive allogeneic B7.1 and human leukocyte antigen-A1 (HLA-A1) transfected tumor cell vaccine intradermally (ID) in weeks 1, 3, and 5. Treatment repeats every 6 weeks for 2 courses. If no more than 1 of 6 patients experience a probable or definitively treatment related adverse effect (i.e., grade 2 autoimmune or grade 3-4 of any type), patients proceed to the phase II portion of the study. If 2 or more (out of 6) patients experience treatment related adverse effects the study stops.

  • Phase II (randomized): Patients are stratified according to study site (University of Miami Sylvester Comprehensive Cancer Center or Memorial Regional Hospital), type of prior first-line treatment (platinum and taxane vs platinum and gemcitabine), and presence of brain metastasis (yes vs no). Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive allogeneic B7.1 and HLA-A1 transfected tumor cell vaccine ID in weeks 1, 3, and 5. Treatment repeats every 6 weeks for 2 courses.
    • Arm II: Patients receive a placebo vaccine as in arm I. Patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for cluster of differentiation 8 (CD8), cluster of differentiation 4 (CD4), and natural killer cell (NK) response and peripheral blood lymphocytes (PBL) and T helper cell 1 (TH1)/T helper cell 2 (TH2) bias, including levels of interleukin (IL) IL-1β, IL-2, IL-4, IL-5, IL-6, IL-13, Interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α) via ELISA.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 4 years, and then once a year thereafter.

PROJECTED ACCRUAL: A total of 66 patients (6 patients for phase I and 60 patients for phase II) will be accrued for this study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Florida
      • Hollywood, Florida, Stati Uniti, 33021
        • Memorial Regional Hospital
      • Miami, Florida, Stati Uniti, 33136
        • University of Miami Sylvester Comprehensive Cancer Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

INCLUSION CRITERIA

  • Patients with stage IIIB (non-candidates for radiation) or stage IV pathologically confirmed non-small cell carcinoma of the lung that completed 4-6 cycles of platinum based first line chemotherapy and achieved complete response (CR), partial response (PR) or stable disease.
  • Last administration of chemotherapy occurred no later than 4 weeks prior to the enrollment date.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Renal Requirements: The calculated creatinine clearance must be at least 50 ml/min.

  • Pulmonary Function Requirements:

    • All patients will undergo evaluation of pulmonary function prior to enrollment.
    • Patients should have a Forced expiratory volume in 1 second (FEV1) more than 30% of the predicted value and/or Diffusing capacity (DLCO) more than 30% of the predicted value with a partial pressure of carbon dioxide (PCO2) < 45mm.
    • Any patient enrolled in the protocol whose respiratory symptoms have experienced marked deterioration not related to a known cause (e.g. pneumonia, congestive heart failure (CHF) or pulmonary embolism (PE)) will have request pulmonary function test (PFT) evaluation and if the above parameters are seen will be excluded from the protocol.
  • Age ≥ 18 years.
  • Signed informed consent.
  • Patients should have absolute neutrophil count (ANC) ≥ 1000/mm3; platelets (PLT) ≥ 80,000/mm3.

EXCLUSION CRITERIA:

  • Small cell carcinoma of the lung.
  • Existing autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease etc; colitis, inflammatory bowel disease or pancreatitis within 10 years of study.
  • Other active malignancies present within the past three years, except for basal and/or squamous cell carcinoma(s) or in situ cervical cancer.
  • Concomitant steroid or other immunosuppressive therapy.
  • Active infection, or less than 7 days since therapy for acute infections.
  • Pericardial effusion.
  • Currently receiving chemotherapy for another condition (such as arthritis).
  • Time elapsed greater than 4 weeks since last administration of first line chemotherapy for NSCLC.
  • Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction.
  • Pregnant or lactating women (negative test for pregnancy required of women of childbearing potential).
  • Refusal in fertile men or women to use effective birth control measures during and for six months after the completion of treatment on study.
  • Known HIV infection
  • Untreated or uncontrolled brain metastasis.
  • Liver Enzymes greater than 3 times the institutional upper limit.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm I: Allogeneic B7.1/HLA-A1

Patients will receive Allogeneic B7.1/HLA-A1 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.

Given intradermally.
Biologico: Allogeneic B7.1/HLA-A1
Dose: At least 4x10^7 irradiated HLA/B7.1 transfected AD100 cells Given intradermally
Altri nomi:
  • - B7.1
  • - B7
  • - Ad100-B45-Neo-B7.1-HLA A1 or HLA2
Comparatore placebo: Arm II: Placebo
Patients receive a placebo vaccine intradermally once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.
Altro: Placebo
Given intradermally

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Preliminary Safety Profile (Phase 1)
Lasso di tempo: Up to 13 weeks
This will include the number of patients experiencing toxicity over the course of treatment, characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.
Up to 13 weeks
Progression-free Survival (Phase 2)
Lasso di tempo: Date of randomization to the earliest date of documented progression.
Date of randomization to the earliest date of documented progression.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Immune Response (CD8) in B7-vaccinated Participants as Compared to Controls. (Phase 2)
Lasso di tempo: About 13 weeks
Rate of immune response (CD8) in B-7 vaccinated participants reported for measurements taken immediately prior to vaccination (week 0) and throughout the two courses.
About 13 weeks
Relationship of CD8 Response in B7-vaccinated Patients to Their Progression-free Survival.(Phase 2)
Lasso di tempo: From Week 1 of Study Therapy until Death or Withdrawal of Consent
Relationship of CD8 response in B7-vaccinated patients to their progression-free survival. Summarized by the median and range of follow up time for patients grouped according to disease status (progression/no progression) and vital status (died/alive at last contact).
From Week 1 of Study Therapy until Death or Withdrawal of Consent
Safety Profile (Phase 2)
Lasso di tempo: About 13 weeks
The rate of patients experiencing toxicity over the course of treatment will be characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination.
About 13 weeks
Response to Second-line Chemotherapy After Disease Progression (Phase 2)
Lasso di tempo: From Week 1 of Study Therapy until Death or Withdrawal of Consent
The percentage of patients experiencing a clinical response (complete response (CR), partial response (PR), stable disease (SD)) on second-line chemotherapy will be characterized for B7-vaccinated patients and controls.
From Week 1 of Study Therapy until Death or Withdrawal of Consent
Overall Survival (Phase 2)
Lasso di tempo: Date of randomization to the recorded date of death
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that study participants are still alive.
Date of randomization to the recorded date of death
Correlative Immunological Studies in Study Participants (Phase 2)
Lasso di tempo: Baseline, Week 7 and Week 13
The time course of patients' adaptive immune response to B7 vaccination as compared to control vaccine will be characterized by their CD8, CD4, and NK response (measured by ELI-spots for interferon-gamma (IFN-γ), interleukin 4 (IL-4), and granzyme B secretion) measured prior to vaccination (i.e. at baseline) and over two courses of vaccination (measurements at week 7 and 13).
Baseline, Week 7 and Week 13

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Miami

Investigatori

  • Cattedra di studio: Luis E. Raez, MD, FACP, University of Miami Sylvester Comprehensive Cancer Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2009

Completamento primario (Effettivo)

1 aprile 2010

Completamento dello studio (Effettivo)

1 aprile 2010

Date di iscrizione allo studio

Primo inviato

20 settembre 2007

Primo inviato che soddisfa i criteri di controllo qualità

20 settembre 2007

Primo Inserito (Stima)

24 settembre 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 ottobre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 settembre 2017

Ultimo verificato

1 settembre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 20057158
  • SCCC-2005042 (Altro identificatore: UM/Sylvester Comprehensive Cancer Center)
  • WIRB-20051678 (Altro identificatore: Western IRB (WIRB))

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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