Phase I Trial of Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer

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.

2. For the purpose of the Pediatric study patients with histologic diagnosis of ESFT
including: Ewing 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)

- Large tumors > 8 cm

- Pelvic osseous tumors ANY SIZE

- Bilateral pulmonary metastasis

- >2 unilateral pulmonary metastasis

4. 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.

5. 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.

6. Recovered from all clinically relevant toxicities related to prior therapies.

7. 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.

8. Age ≥12 years.

9. ECOG performance status (PS) 0-1.Pediatric patients with Lansky or Karnofsky
Performance Status Scale ≥ of 50%.

10. Estimated >4 month survival probability.

11. 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

12. 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.

13. 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 ≤ 0.125 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 (see inclusion
criteria 5).

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. For patients with hepatocellular
carcinoma (HCC), the presence of chronic HBV and HCV is NOT an exclusion.

13. Patients with uncontrolled autoimmune diseases.

14. Patients must be off all "statin" drugs for ≥2 weeks prior to initiation of therapy.