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:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT02379520
Eligibility Criteria:
Inclusion Criteria:
PROCUREMENT
1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample
2. Cancer is:
* recurrent or persistent after standard therapy
* OR patient is unable to receive standard therapy
3. Karnofsky score ≥ 50%
4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
TREATMENT
1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample
2. Cancer is:
* recurrent or persistent after standard therapy
* OR patient is unable to receive standard therapy
3. Life expectancy ≥ 6 weeks.
4. Age ≥ 18 years.
5. Karnofsky score ≥ 50%
6. Bilirubin \< 3 × upper limit of normal (ULN), AST \< 5 × ULN, Hgb ≥ 7.0 g/dL
7. Pulse oximetry of \> 90% on room air.
8. GFR \> 30 mL/min calculated by the Cockcroft-Gault, MDRD study, or CKD-EPI creatinine equations, or equivalent.
9. ANC \> 1.0/μL
10. Platelets \> 75,000/μL
11. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
12. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
Exclusion Criteria:
PROCUREMENT
1\. Known HIV positivity.
TREATMENT
1. Currently receiving any investigational agents or have received any tumor vaccines or T cell antibodies within previous 4 weeks.
2. Severe intercurrent infection.
3. Pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02379520
Study Brief:
Protocol Section:
NCT02379520