Actively Recruiting
Pilot Study of Neoantigen Peptides and Leukine for the Treatment of Neoplasms
Led by Instituto de Medicina Regenerativa · Updated on 2024-03-06
100
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pilot Study of Neoantigen Peptides and Leukine for the Treatment of Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 16 years of age or older, male or female
- Life expectancy of at least 3 months
- Confirmed tumor by imaging studies
- Adequate organ function based on laboratory tests: lymphocyte ratio >20%; WBC >3.0 x 10^9/L; ALT and AST ≤2.5 times upper limit of normal (ULN), or ≤5 times ULN if liver metastases; ALP ≤2.5 times ULN; total serum bilirubin <1.5 times ULN; BUN ≤1.5 times ULN; creatinine ≤1.5 times ULN
- Normal blood coagulation, urine tests, and electrocardiogram (ECG)
- Available tumor specimen for sequencing and neoantigen identification
- Ability to find 3 or more neoantigen epitopes
- Ability to follow study procedures and follow-up
- Able to understand and willing to sign informed consent
- Agree to use contraception or have a partner who agrees to use adequate contraception during the study and for 30 days after completion
You will not qualify if you...
- History of immunodeficiency disorder or autoimmune disease requiring active immunosuppressive therapy
- Evidence of liver or kidney dysfunction, severe heart disease, or coagulation problems
- Known infectious diseases including hepatitis, HIV, CMV, or Treponema pallidum
- Pregnant, breastfeeding, or planning pregnancy during the study
- Psychiatric illness limiting compliance or judged unsuitable for study participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Instituto de Medicina Regenerativa
Tijuana, Estado de Baja California, Mexico, 22100
Actively Recruiting
Research Team
J
Jesus Perez, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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