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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00684294
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed advanced or metastatic non-curable solid tumor (if limited to a single lesion and not a candidate for curative surgery or radiation therapy).
* Completed ≥1 conventional therapy.
* Clinically indicated surgery or procedure to collect available tumor in sufficient quantity ("golf ball size," pleural or ascites fluid may also be collected) for vaccine processing.
* Subjects that have completed all acceptable therapies that are the current standard of care for their respective diseases.
* Recovered from all toxicities related to prior therapies.
* Subjects with brain metastases treated at least ≥2 months prior to enrollment, without related clinical symptoms and must have a stable neurological exam on the screening evaluation.
* ≥1 measurable or evaluable lesion.
* Age ≥18 years.
* ECOG performance status (PS) 0-1.
* Normal organ and marrow function:
* Absolute granulocyte count: ≥1,500/mm3
* Platelets: ≥100,000/mm3
* Total bilirubin: ≤2 mg/dL
* AST(SGOT)/ALT(SGPT): ≤2x institutional upper limit of normal
* Creatinine: \<1.5 mg/dL
* Ability to understand and the willingness to sign a written informed consent document.
* Negative pregnancy test.
Exclusion Criteria:
* Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to entering the study.
* Patient must not have received any other investigational agents within 30 days prior to study entry.
* Patients with known brain metastases unless treated and stable for ≥2 months.
* Patients with mucinous adenocarcinoma.
* Short term (\<30 days) concurrent systemic steroids ≤ 0.125 mg/kg prednisone per day (maximum 10 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded. Patients requiring steroids following previous CNS radiation for metastatic disease are excluded.
* Prior splenectomy.
* Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission for ≥2 years.
* Kaposi's Sarcoma.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients who are pregnant or nursing.
* Patients who are HIV positive.
* Patients with chronic Hepatitis B and C infection.
* Patients with a history of autoimmune diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00684294
Study Brief:
Protocol Section:
NCT00684294