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 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT01671592
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have adequate tumor tissue from surgery, performed as part of their conventional care.
* No chemotherapy, radiotherapy, major surgery, or biologic therapy for their malignancy in the 2 weeks prior to vaccine administration and they must have recovered from all side effects.
* An ECOG performance status of 0, 1, or 2.
* Age equal to 18 years or older.
* Blood tests:
* Platelet counts greater than 80,000 (platelet count, hematocrit, and WBC will be re-evaluated within 2 weeks prior to leukapheresis)
* Hematocrit \> 27.0
* White blood count \> 2000/µL
* Creatinine less than or equal to 2 X ULN
* Aware of the neoplastic nature of his/her illness, the experimental nature of the study intervention, alternative treatments, potential benefits and risks, and willing to sign a written informed consent document.
Exclusion Criteria:
* Subjects currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 2 weeks after removal from immunosuppressive treatment. Subjects on maintenance steroids because of adrenal insufficiency are eligible.
* Subjects with total bilirubin greater than 2 X ULN.
* Subjects with uncontrolled pain.
* Subjects with active autoimmune disease, positive serology for HIV, HBV, or HCV. (Hypothyroidism is allowed.)
* Subjects who are allergic to or develop an allergy to heparin.
* Subjects who are pregnant.
* Subjects who have sensitivity to drugs that provide local anesthesia.
* Subjects who have medical contraindications for MRI. Such contraindications include:
* Electrical implants such as cardiac pacemakers or perfusion pumps
* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye or steel implants
* Ferromagnetic objects such as jewelry or metal clips in clothing
* Pre-existing medical conditions, including claustrophobic reactions, the likelihood of developing a seizure or any greater than normal potential for cardiac arrest
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01671592
Study Brief:
Protocol Section:
NCT01671592