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Randomized Phase II Trial of Post-operative Adjuvant Chemotherapy ± FANG™ Autologous Tumor Cell Vaccine in Colorectal Carcinoma With Liver Metastases

Phase 2
18 Years
Open (Enrolling)
Colon Cancer

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Trial Information

Randomized Phase II Trial of Post-operative Adjuvant Chemotherapy ± FANG™ Autologous Tumor Cell Vaccine in Colorectal Carcinoma With Liver Metastases

Inclusion Criteria:

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 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 +
pulmonary metastases.

2. For patients with 4-6 total lesions, distribution may include liver +/-
pulmonary metastases.

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 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.

Exclusion Criteria:

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
study requirements.

13. Patients with known HIV.

14. Patients with chronic Hepatitis B and C infection.

15. Patients with uncontrolled autoimmune diseases.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Overall Survival Rate

Outcome Description:

To determine the overall survival rate in patients with CLM following resection +/= ablation with curative intent treated with adjuvant chemotherapy and FANG™ vaccine versus adjuvant chemotherapy and placebo and compare with historical data

Outcome Time Frame:

24 Months

Safety Issue:


Principal Investigator

Minal Barve, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mary Crowley Cancer Research Centers


United States: Food and Drug Administration

Study ID:

CL-PTL 107



Start Date:

March 2012

Completion Date:

January 2015

Related Keywords:

  • Colon Cancer
  • colorectal carcinoma
  • colon cancer
  • liver metastases
  • Carcinoma
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms



Mary Crowley Cancer Research Centers Dallas, Texas  75201