Not yet recruitingPhase 2

Testing the SurVaxM Vaccine for Lung Cancer Prevention

Evaluating the Feasibility of a Survivin Peptide Vaccine (SurVaxM) as an Interception Agent in Patients at High Risk for Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients also undergo collection of blood samples throughout the trial."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the SurVaxM vaccine can help prevent lung cancer in adults at high risk who smoke or used to smoke. The vaccine aims to help the immune system attack cells with a protein called survivin. It is given with two other drugs that help the immune system respond.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Smoke now or have smoked in the past, with at least 20 pack-years of smoking, such as 1 pack a day for 20 years.
  • Have a lung cancer risk score above 1.34% using the study’s PLCOm2012 risk tool.
  • Meet the study’s physical activity rating: ECOG 0–1 or Karnofsky at least 60%.
  • Have at least 100,000 platelets per microliter of blood. Platelets help blood clot.
  • Meet liver and kidney blood test limits, usually no more than 1.5 times the lab’s upper normal limit. A higher bilirubin level may be allowed for a harmless liver condition such as Gilbert’s.
  • Agree to use birth control or avoid sex before joining and during the study if you or your partner could become pregnant.
  • Be able and willing to understand and sign a consent form.

Who can't join

  • Have a history of an immune system disease needing drugs that weaken immunity, a weak immune system, or an organ transplant.
  • Receive chemotherapy other than hormone treatment, immune-based cancer treatment, an experimental drug, or drugs that weaken immunity, including steroids that act throughout the body.
  • Have current or past cancer, unless it meets an allowed exception. Exceptions include certain treated early or skin cancers, cancer treated to cure it with no active disease for over 3 years and a low risk of return, or cancer that would not affect study results or safety.
  • Have had an allergic reaction to substances similar to montanide or GM-CSF, a drug that helps increase white blood cells.
  • Have an uncontrolled illness, mental illness, or life situation that would prevent you from following study requirements.
  • Be pregnant. If breastfeeding, you must stop while receiving SurVaxM with montanide.
  • Be in another cancer-prevention trial using a drug that changes immune activity, or be within its required 6-month waiting period.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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%) * Platelets \>= 100,000/microliter * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) * Note: Higher total bilirubin levels (=\< 3 mg/dL) can be allowed if due to known benign liver condition, i.e. Gilbert's * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x institutional upper limit of normal * Serum creatinine =\< 1.5 x institutional upper limit of normal * The effects of SurVaxM plus montanide on the developing human fetus at the recommended therapeutic dose are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * 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 * Participants with current or prior malignancy except for the following: * 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 * Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer * Prior or current malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (e.g., localized prostate cancer) may be included * History of allergic reactions attributed to compounds of similar chemical or biologic composition to montanide or granulocyte-macrophage colony-stimulating factor (GM-CSF) * Uncontrolled intercurrent illness, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because of the unknown effects of SurVaxM plus montanide on the fetus. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with SurVaxM plus montanide, breastfeeding should be discontinued if the mother is treated with SurVaxM plus montanide * Individuals participating in another interception trial with an immunomodulatory agent will be excluded from participation in this trial for a washout period of 6 months

Study sites (4)

CO

IL

NY

TN