Pilot Study of Neoantigen Peptides and Leukine for the Treatment of Neoplasms

Summary

The present study is a pilot clinical trial using personalized neoantigen peptide vaccines with the addition of Leukine (Sargramostim), in patients with different types of cancer.

Eligibility

Inclusion Criteria:

* 16 years of age or older, male or female
* Life expectancy of at least 3 months
* Confirmed tumor by imaging studies
* Have adequate organ function, as measured by laboratory values: Lymphocyte ratio \>20%; WBC \>3.0×10\^9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; if the patient has liver metastases, ALT and AST ≤5 × ULN; Alkaline phosphatase (ALP）≤2.5 × ULN; total serum bilirubin (TBIL) \< 1.5 × ULN; Urea nitrogen (BUN）≤1.5 × ULN; Creatinine (Cr）1.5≤ULN; Normal blood coagulation function, urine routine, and electrocardiogram (ECG)
* Available tumor specimen for sequencing and neoantigen determination
* Ability to find 3 or more neoantigen epitopes
* Ability to follow research and follow-up procedures
* Able to understand and willing to sign an IRB approved written informed consent document
* Agree with the use of contraception or partner of child-bearing potential agrees to use adequate contraception which will include two of the following: hormonal or barrier method of birth control, or abstinence prior to study entry, for the duration of study participation, and for 30 days following completion of therapy

Exclusion Criteria:

* History of immunodeficiency disorder or autoimmune condition requiring active immunosuppressive therapy
* Evidence of Liver and kidney dysfunction, severe heart disease, or coagulation dysfunction
* Known diagnosis of an infectious condition including hepatitis, HIV, CMV, and Treponema pallidum
* Participant becomes pregnant and/or is breastfeeding or plans on becoming pregnant during study
* A psychiatric illness that would limit compliance with study requirements as determined by the investigator or the investigator believes that participant is not suitable for inclusion

Conditions2

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