Clinical Trials /

Vaccination of Advanced-Stage Lung Cancer Patients

NCT02264236

Description:

The overarching purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung Cancer. Vaccine will consist of P10s-PADRE admixed with an adjuvant, MONTANIDETM ISA 51 VG. Up to one hundred fifty (150) subjects with advanced-stage Lung Cancer of any histologic type will be enrolled for this vaccine trial. This single-arm, multi-site trial is designed to evaluate the therapeutic benefits of the vaccine in subjects with advanced-stage lung cancer. The primary objectives of the study are: (1) to monitor the safety and tolerability of the vaccine when it is administered in combination with SoC therapy; and (2) to determine whether immunization with vaccine can successfully elicit a robust immune response in subjects with advanced-stage lung cancer.

Related Conditions:
  • Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Vaccination of Advanced-Stage Lung Cancer Patients
  • Official Title: "Vaccination of Advanced-Stage Lung Cancer Patients" A Phase I/II Study of a Carbohydrate Mimotope Based Vaccine With MONTANIDETM ISA 51 VG ST Adjuvant

Clinical Trial IDs

  • ORG STUDY ID: 203199
  • SECONDARY ID: 203199
  • NCT ID: NCT02264236

Conditions

  • Lung Neoplasms

Interventions

DrugSynonymsArms
P10s-PADRE vaccineMimotope P10s-PADRE VaccineP10s-PADRE vaccine

Purpose

The overarching purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard-of-care (SoC) treatment in subjects with advanced-stage (i.e., metastatic) Lung Cancer. Vaccine will consist of P10s-PADRE admixed with an adjuvant, MONTANIDETM ISA 51 VG. Up to one hundred fifty (150) subjects with advanced-stage Lung Cancer of any histologic type will be enrolled for this vaccine trial. This single-arm, multi-site trial is designed to evaluate the therapeutic benefits of the vaccine in subjects with advanced-stage lung cancer. The primary objectives of the study are: (1) to monitor the safety and tolerability of the vaccine when it is administered in combination with SoC therapy; and (2) to determine whether immunization with vaccine can successfully elicit a robust immune response in subjects with advanced-stage lung cancer.

Trial Arms

NameTypeDescriptionInterventions
P10s-PADRE vaccineExperimentalSubjects will be immunized by administration of either three or four doses of P10s-PADRE vaccine over a six-week period at a dose level of 500 micrograms (µg) per injection depending on the slandered of care therapy they receive for their lung cancer.
  • P10s-PADRE vaccine

Eligibility Criteria

        Inclusion Criteria:

          1. Advanced-stage (i.e., metastatic) Lung Cancer of any histologic type

          2. (Computed Tomography) CT scans were completed within 4 weeks prior to registration

          3. Age 18 years and older

          4. ECOG Performance Status 0 to 2

          5. White blood cell (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration

          6. Platelet count ≥ 100,000/mm3 within 3 weeks prior to registration

          7. Serum glutamic-pyruvic transaminase (SGPT) or alanine aminotransferase test (ALT) ≤ 2
             x institutional upper limit (IUL) of normal obtained within 3 weeks prior to
             registration

          8. Serum glutamic-oxaloacetic transaminase (SGOT) or aspartate aminotransferase test
             (AST) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to
             registration

          9. Serum creatinine ≤ 1.8 mg/dL obtained within 3 weeks prior to registration

         10. Radiation is allowed

        Exclusion Criteria:

          1. Active infection requiring treatment with antibiotics

          2. Any other significant medical or psychiatric conditions which, in the opinion of the
             enrolling investigator, may interfere with consent or compliance of the treatment
             regimen

          3. Existing diagnosis or evidence of organic brain syndrome that might preclude
             participation in the full protocol

          4. Existing diagnosis or history of significant impairment of basal cognitive function
             that might preclude participation in the full protocol

          5. Existing diagnosis or history of leptomeningeal disease, spinal cord compression or
             brain metastases unless: (a) metastases have been locally treated and have remained
             clinically controlled and asymptomatic for at least 14 days following treatment, AND
             (b) subject has no residual neurological dysfunction and has been off corticosteroids
             for at least 14 days prior to registration

          6. Other current malignancy(s): Subjects with prior history at any time of any in situ
             cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ,
             atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin
             cancer are eligible, provided they are disease-free at the time of registration.
             Subject has other malignancies have been continuously disease free for ≥ 5 years prior
             to the time of registration. Subjects with other malignancies are eligible if they
             have been continuously disease free for ≥ 5 years prior to the time of registration.

          7. Active autoimmune disorders or conditions of immunosuppression; Existing autoimmune
             disorders or conditions of immunosuppression that have been in remission for less than
             6 months.

          8. Treatment with corticosteroids, including oral steroids (i.e. prednisone,
             dexamethasone), continuous use of topical steroid creams or ointments or any
             steroid-containing inhalers. Subjects who have been on systemic steroids will require
             a 6-week washout period. Subjects who discontinue the use of these classes of
             medication for at least 6 weeks prior to registration are eligible if, in the judgment
             of the treating physician, the subject is not likely to require these classes of drugs
             during the treatment period. Replacement doses of steroids for subjects with adrenal
             insufficiency are allowed.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with vaccine related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time Frame:64 weeks +/- 2 weeks per subject
Safety Issue:
Description:The National Cancer Institute (NCI) of the National Institutes of Health (NIH) has published standardized definitions for adverse events (AEs), known as the Common Terminology Criteria for Adverse Events (CTCAE, also called "common toxicity criteria"), to describe the severity of organ toxicity for patients receiving cancer therapy. The tables describing AEs graded in the CTCAE (version 4.0) provides a references for adverse events reporting. From grade 1 AEs being minor/low grade adverse events to grade 5 AEs being serious adverse events usually resulting in death.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Arkansas

Last Updated

April 5, 2021