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Combination of gp96-Ig Vaccine, Theophylline and Oxygen for the Treatment of Patients With Advanced, Relapsed or Metastatic Non-Small Cell Lung Cancer

NCT01799161 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-11-17

No results posted yet for this study

Summary

NSCLC tumors are appropriate targets for active immunotherapy, because they are non-immunogenic, which indicates that NSCLC does not stimulate a spontaneous immune response.

NSCLC tumor-secreted gp96-Ig is an ideal vaccine because it combines adjuvant activity with polyvalent peptide specificity. Tumor secreted gp96 activates dendritic cells (DC), natural killer cells (NK) and cytotoxic T lymphocytes (CTL). Tumor cells can be killed by NK-specific mechanisms, by promiscuous killing of CD8 CTL through NKG2D, and by MHC restricted CD8 CTL activity. The activation of DC and NK by tumor secreted gp96 may also counteract the generation of immuno-suppressive CD4 regulatory cells.

Suppression of adenosinergic pathways by oxygen and theophylline in combination with immunotherapy will improve tumor rejection.

Allogeneic, gp96-Ig secreting tumor cells used as vaccine are expected to generate NK and CTL with activity to the patient's autologous tumor.

Conditions

Interventions

BIOLOGICAL

gp96-Ig Vaccine

DRUG

Theophylline

300 mg capsule daily of Theophylline during 1st course, then adjusted dose

OTHER

Oxygen

24-hr oxygen delivered via nasal cannula or oxygen mask during 1st course, then adjusted dose.

PROCEDURE

Immunologic Evaluation

Frequency of IFN-y,CD8 cells in response to vaccine in available tumor samples Blood draw to assess immunological response \[frequency of CD4+, FoxP3 (Treg), et al\] in treated patients.

Sponsors & Collaborators

  • Eckhard Podack

    lead OTHER

Principal Investigators

  • Ikechukwu Akunyili, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2018-04-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01799161 on ClinicalTrials.gov