Please assess the completion status of the following clinical trial:

Trial Title: Trial of Bi-shRNA-furin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 3.0

Eligibility Criteria:
Tissue Procurement Inclusion Criteria:~1. Presumptive or histologically confirmed advanced or metastatic non-curable solid tumor (if limited to a single lesion, and may not be a candidate for curative surgery or radiation therapy).~2. For the purpose of the Pediatric study patients with histologic diagnosis of ESFT including: Ewing's sarcoma or primitive neuroectodermal tumor (malignant neuroepithelioma) of the bone or soft tissues, Askin's tumor of the chest and with central nervous system tumors are eligible.~3. Patients with recurrent or refractory ESFT. Patients with de novo poor prognosis/high risk ESFT: (Eligible for vaccine manufacturing at diagnosis but ONLY ELIGIBLE FOR IMMUNOTHERAPY IF DEMONSTRATES PERSISTENT/RECURRENT/ REFRACTORY DISEASE)~   1. Large tumors \> 8 cm~  2. Pelvic osseous tumors ANY SIZE~  3. Bilateral pulmonary metastasis~  4. \>2 unilateral pulmonary metastasis~4. Clinically (medically) indicated procedure (i.e. biopsy of lesions of recurrent disease, palliative management via resection, thoracentesis, etc.) to collect tumor in sufficient quantity (golf ball size estimated weight 10-30 grams, pleural, and/or ascites fluid estimated volume ≥ 500 mL) for vaccine processing.~5. For ESFT patients age ≥12 years.~6. Age ≥18 years (non-ESFT candidates) ECOG performance status (PS) 0-1. Pediatric patients with Lansky or Karnofsky Performance Status Scale ≥ of 50%.~7. Estimated \>4 months survival probability.~8. Ability to understand and the willingness to sign a written informed consent document. Pediatric patients must sign an assent with a parent or legal guardian sign a written informed consent.~Inclusion Criteria:~1. Histologically confirmed advanced or metastatic non-curable solid tumor (if limited to a single lesion may not be a candidate for curative surgery or radiation therapy). Successful vaccine manufacture has resulted from tissue/fluid obtained from the following major organ systems: digestive, endocrine, reproductive, respiratory, and urinary.Individuals manufactured under CL-PTL 105 (Phase II Ovarian) may be eligible for enrollment without advanced or metastatic disease.~2. Patients with well differentiated thyroid cancer are eligible for protocol as follows:~   1. Surgically unresectable locally recurrent disease and/or metastatic disease following RAI ablation (if locally recurrent and ultrasound (US) positive, baseline FDG-PET or MRI will be obtained).~  2. Patients with microscopic and/or gross extra thyroidal disease extension without RAI uptake but with a) FDG-PET positive disease or b) suppressed thyroglobulin \>1 ng/mL or c) stimulated thyroglobulin \>10 ng/L.~  3. Patients with tracheal/esophageal involvement. High mitotic activity or necrosis in pathology does not exclude from the study.~   Note: in Categories a and b, patients can be followed using US locally in addition to standard diagnostic followup menu but, if US only is positive, a FDG-PET or MRI will be obtained. If negative, a rising thyroglobulin titer is required in which case response will be monitored by continued US and suppressed and/or stimulated thyroglobulin. Thyroglobulin titer cannot be used if anti-thyroglobulin antibodies are present).~3. Completed all acceptable therapies with curative intent that are the current standard of care for their respective diseases. If no conventional therapy available, patient may participate after review by sponsor.~4. Recovered 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. For ESFT patients age ≥12 years.~7. Age ≥18 years (non-ESFT candidates)~8. ECOG performance status (PS) 0-1.Pediatric patients with Lansky or Karnofsky Performance Status Scale ≥ of 50%.~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. Pediatric patients must sign an assent with a parent or legal guardian sign a written informed consent.~12. Negative pregnancy test.~13. Patients must be off all statin drugs for ≥2 weeks prior to initiation of therapy.~Exclusion Criteria:~1. Surgery involving general anesthesia, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to entering the study. Palliative radiotherapy is allowable. Collection of lumenal tissue for vaccine manufacture must be avoided.~2. Patients must not have received any other investigational agents within 30 days prior to vaccination.~3. Concurrent tumor-specific hormonal therapy or antiestrogens. (Individuals manufactured under CL-PTL 105 (Phase II Ovarian) are not subject to this exclusion).~4. Patients with known active or symptomatic brain metastases prior to vaccination.~5. Patients with compromised pulmonary disease.~6. 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 while receiving vaccine. Patients requiring steroids following previous CNS radiation for metastatic disease are excluded.~7. Prior splenectomy unless Howell-Jolly bodies are absent.~8. Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission for 2 years.~9. Kaposi's Sarcoma.~10. 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.~11. Patients who are pregnant or nursing.~12. Patients with known HIV.~13. Patients with chronic Hepatitis B and C infection. For patients with hepatocellular carcinoma (HCC), the presence of chronic HBV and HCV is NOT an exclusion. Patients must have a viral titer \<50 IU/ml x 2 at a minimum of 2 weeks apart.~14. Patients with uncontrolled autoimmune diseases.

- Gender: ALL
- Minimum Age: 12 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- 1 x 10 ^7 cells/injection (Type: EXPERIMENTAL): Vigil™
- 2.5 x 10 ^7 cells/injection (Type: EXPERIMENTAL): Vigil™
- 1 x 10^6 or 4 x 10^6 cells/injection (Type: EXPERIMENTAL): Vigil™

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete