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 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT01453361
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed Stages IIIc and IV melanoma.
2. Has been informed of all alternative ≥ second-line therapies that are the current standard of care. If no conventional frontline therapy indicated or acceptable by patient, patient may participate after review by sponsor.
3. Clinically (medically) indicated procedure (i.e. biopsy of lesions of recurrent disease, palliative management via resection, thoracentesis, etc.) to collect viable tumor in sufficient quantity ("golf ball size" estimated weight \~ 30 grams, pleural and/or ascites fluid estimated volume ≥ 500mL) for vaccine processing.
4. Recovered to ≤ Grade 1 (excluding alopecia) from all clinically relevant toxicities related to prior therapies.
5. Patients will be allowed to participate following single prior CNS treatment with stereotactic radiotherapy whole brain irradiation and stable without steroid requirement for ≥2 months or following ≥2 prior CNS treatments with stereotactic radiotherapy whole brain irradiation and stable without steroid requirement for ≥4 months.
6. Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
7. Age ≥18 years.
8. ECOG performance status (PS) 0-1.
9. Estimated \>4 month survival probability.
10. Normal organ and marrow function as defined below:
Absolute granulocyte count ≥1,500/mm3 Absolute lymphocyte count ≥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
11. Ability to understand and the willingness to sign a written informed consent document.
12. Negative pregnancy test.
Exclusion Criteria:
1. Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to entering the study. Collection of lumenal tissue must be avoided.
2. Patient must not have received any other investigational agents within 30 days prior to study entry.
3. Patients with known active or symptomatic brain metastases.
4. Patients with compromised pulmonary disease.
5. Short term (\<30 days) concurrent systemic steroids ≤ 0.25 mg/kg prednisone per day (maximum 7.5 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.
6. Prior splenectomy.
7. Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission for 2 years.
8. Kaposi's Sarcoma.
9. 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.
10. Patients who are pregnant or nursing.
11. Patients with known HIV.
12. Patients with chronic Hepatitis B and C infection.
13. Patients with uncontrolled autoimmune diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01453361
Study Brief:
Protocol Section:
NCT01453361