The P10s-PADRE Basket Trial: Vaccination of Metastatic Cancer Patients (NCT03003195) | Clinical Trial Compass
WithdrawnPhase 2
The P10s-PADRE Basket Trial: Vaccination of Metastatic Cancer Patients
Stopped: Lack of Funding
0Started 2021-03-01
Plain-language summary
The purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine in subjects with metastatic cancer.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects of all races with clinical Stage IV cancer of any type, staged according to American Joint Commission on Cancer (AJCC), sixth edition, receiving any line of standard treatment for the specific cancer and with stable disease or better for at least two months will be invited to participate.
* Subjects of all races with clinical Stage IV cancer of any type, staged according to American Joint Commission on Cancer (AJCC), sixth edition, who have no standard treatment options for the specific cancer (Patients whose standard of care consists of watchful waiting) and who fulfill the other eligibility criteria will be invited to participate.
* Measurable or evaluable disease.
* Patients with bone-only disease will be allowed to participate.
* Ages 18 years and older.
* ECOG Performance status 0, 1 or 2.
* White blood cells (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration
* Platelet count ≥ 100,000/mm3 prior to registration
* Serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration or Aspartate aminotransferase test (AST) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration
* Bilirubin ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to registration.
* Serum creatinine ≤ 1.8 mg/dl obtained within 3 weeks prior to registration.
* Must sign an informed consent document approved by UAMS Institu…