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Testing the SurVaxM Vaccine for Lung Cancer Prevention

ConditionLung Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

This phase II trial tests how well a survivin peptide vaccine called SurVaxM works in preventing lung cancer in high risk patients. Upon administration, the SurVaxM vaccine activates the immune system to produce an immune cell response against cancer cells that express a protein called survivin. This may result in decreased tumor cell proliferation and lead to tumor cell death. SurVaxM is given with montanide, a substance that helps the immune system respond to the SurVaxM vaccine, followed by sargramostim, which is given to increase the number of white blood cells in the body. The SurVaxM vaccine may help the body make special proteins called antibodies, which may be helpful in preventing the development of lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Former and current smokers (male and female) with a >= 20 pack year smoking history

Prostate, Lung, Colorectal and Ovarian (PLCO)m2012 Lung Cancer Risk Prediction Score > 1.34%

Participants >= 18 years old will be enrolled. Because no dosing or adverse event (AE) data are currently available on the use of SurVaxM in participants < 18 years of age, children and adolescents are excluded from this study but will be eligible for future pediatric trials, if applicable

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 60%)

Disqualifiers

History of autoimmune disease necessitating systemic immunosuppression, immunodeficiency, and/or organ allograft

Participants may not be receiving any other chemotherapy (except hormonal agents), immunotherapy or investigational agent, or any immunosuppressive agent, including systemic steroids, including those given after organ transplant

Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years before screening and felt to be at low risk for recurrence by treating physician

Adequately treated carcinoma-in-situ or basal cell carcinoma of the skin without current evidence of disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Montanide ISA 51 VG

    Drug

    Given SC

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Sargramostim

    Biological/Vaccine

    Given SC

  • SVN53-67/M57-KLH Peptide Vaccine

    Biological/Vaccine

    Given SC

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Prevention (SurVaxM, montanide, sargramostim)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Seroconversion rate

Seroconversion rate will be summarized as the frequency and proportion of participants who achieved sufficient seroconversion, which will be reported with the corresponding 95% confidence intervals. A one-sample exact test for one proportion will be used to test whether seroconversion rate exceeds the unacceptably low rate of 50%.

Time frame
Up to week 20

Secondary outcomes

1

Proportion of participants who require a 3-month booster to achieve seroconversion

Proportions will be reported with the corresponding confidence intervals.

Time frame
At week 18
2

Proportion of participants who achieve seroconversion

Proportions will be reported with the corresponding confidence intervals.

Time frame
By 3 months
3

Proportion of participants who do not achieve seroconversion at 3 months but achieve seroconversion 2-4 weeks after receiving a 3-month booster

Proportions will be reported with the corresponding confidence intervals.

Time frame
Up to week 20
4

Proportion of participants who do not achieve seroconversion

Proportions will be reported with the corresponding confidence intervals.

Time frame
Up to week 20

Other outcomes

1

Seroconversion rate

Will perform exploratory analyses associating participants' demographic and clinical characteristics with outcomes using Wilcoxon ranksum tests to compare continuous variables between responders and non-responders using Fisher's exact test or chi-squared test to compare categorical variables between responders and non-responders. Multivariable logistic regression models will be used to examine the effects of multiple risk factors simultaneously.

Time frame
Up to week 20
2

Proportion of participants who require a 3-month booster to achieve seroconversion

Will perform exploratory analyses associating participants' demographic and clinical characteristics with outcomes using Wilcoxon ranksum tests to compare continuous variables between responders and non-responders using Fisher's exact test or chi-squared test to compare categorical variables between responders and non-responders. Multivariable logistic regression models will be used to examine the effects of multiple risk factors simultaneously.

Time frame
At week 18

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: