Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT02239861
Eligibility Criteria:
THIS PROTOCOL IS CURRENTLY NOT RECRUITING ADULTS.
Procurement Inclusion Criteria:
1. Any patient regardless of sex with a solid tumor expressing any of the following antigens (PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or Survivin) with:
1. Active disease after first line therapy;
2. Refractory disease;
3. As adjuvant therapy for high risk disease (high risk disease is a disease that has a \>50% risk of progression within 5 years)
2. Patients with life expectancy at least 6 weeks.
3. Age greater than or equal to 2 and less than or equal to 80 years old.
4. Hgb \>8.0
5. Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
Procurement Exclusion Criteria:
1. Diagnosis of primary CNS tumor.
2. Patients with severe intercurrent infection.
3. Patients with active HIV infection at time of procurement (can be pending at the time of blood draw).
4. Patients in remission who are enrolled on another study where time to progression or disease-free survival is a primary endpoint.
Treatment Inclusion Criteria:
1. Any patient regardless of sex with a solid tumor expressing any of the following antigens (PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or Survivin) with:
1. Active disease after first line therapy;
2. Refractory disease;
3. As adjuvant therapy for high risk disease (high risk disease is a disease that has a \>50% risk of progression within 5 years)
2. Patients with life expectancy at least 6 weeks.
3. Age greater than or equal to 2 and less than or equal to 80 years old.
4. Pulse oximetry of \>95% on room air in patients who previously received radiation therapy.
5. Patients with a Karnofsky/Lansky score of greater than or equal to 50.
6. Patients with bilirubin less than or equal to 2x upper limit of normal, AST less than or equal to 3x upper limit of normal, and Hgb \>8.0
7. Patients with a creatinine less than or equal to 2x upper limit of normal for age.
8. Patients should have been off other investigational therapy for one month prior to entry in this study.
9. Patients should have been off conventional therapy for at least 1 week prior to entry in this study. PD1/PDL1 inhibitors will be allowed if medically indicated.
10. Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
11. Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation.
Treatment Exclusion Criteria:
1. Diagnosis of primary CNS tumor.
2. Patients with severe intercurrent infection.
3. Patients receiving systemic corticosteroids (patients off steroids for at least 48 hours are eligible).
4. Pregnant or breastfeeding
5. HIV positive.
6. Patients in remission who are enrolled on another study where time to progression or disease-free survival is a primary endpoint.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
80 Years
Study:
NCT02239861
Study Brief:
Protocol Section:
NCT02239861