Randomized Phase II Trial of Post-operative Adjuvant Chemotherapy ± FANG™ Autologous Tumor Cell Vaccine in Colorectal Carcinoma With Liver Metastases
1. Histologically confirmed colorectal carcinoma with synchronous or metachronous liver
metastases +/- pulmonary metastases.
2. Part 1 patients: May have multiple number of metastatic lesions as long as they can
be rendered no evidence of disease (NED).
3. Part 2 patients: Maximum total number of metastatic lesions = 6. (Patients with
CLM with EHD other than lung will be evaluated on an individual basis by the
1. For patients with 1-3 total lesions, distribution must include both liver +
2. For patients with 4-6 total lesions, distribution may include liver +/-
4. Candidate for surgical excision +/= ablation with curative intent based on
pre-operative assessment incorporating a CT/PET scan.
5. Has been informed of all alternative ≥ first and/or 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.
6. Planned resected viable tumor in sufficient quantity ("golf ball size" estimated
weight ~ 30 grams) for vaccine processing.
7. Recovered to ≤ Grade 1 (excluding alopecia) from all clinically relevant toxicities
related to prior therapies.
8. Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
9. Age ≥18 years.
10. ECOG performance status (PS) 0-2.
11. Estimated >4 month survival probability.
12. 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
13. Ability to understand and the willingness to sign a written informed consent
14. Negative pregnancy test.
1. Surgery involving general anesthesia, radiotherapy, steroid therapy, or immunotherapy
within 4 weeks prior to entering the study. Collection of lumenal tissue must be
2. Prior therapeutic chemotherapy (excluding protocol defined sandwich chemotherapy).
Prior approved sandwich / adjuvant therapy is permitted maximum of 3 cycles (1 cycle
= 2 biweekly courses / 1 month) anterior therapy and at least 6 months between
cessation of chemotherapy and the diagnosis of metastatic disease.
3. Prior surgical resection, ablation or radiation therapy for metastatic disease.
4. Portal, celiac or periaortic metastases.
5. Patient must not have received any other investigational agents within 30 days prior
to study entry.
6. Patients with known active or symptomatic brain metastases.
7. Patients with compromised pulmonary disease.
8. 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.
9. Prior splenectomy.
10. Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission
for ≥ 2 years.
11. Kaposi's Sarcoma.
12. 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
13. Patients with known HIV.
14. Patients with chronic Hepatitis B and C infection.
15. Patients with uncontrolled autoimmune diseases.