Autologous prime-boost anti-tumor vaccination in patients with hepatoma or metastatic cancers (pancreas, neuroendocrine, gastric, colon, breast) to the cancer in the liver
http://clinicaltrials.gov/ct2/show/NCT00553683


This is a phase I/IIa clinical trial using 1) low dose cyclophosphamide to reduce tumor driven immune tolerance, 2) low dose 3D conformational radiation to the tumor, to increase expression of tumor antigens, 3) injection of an immune adjuvant, the toll like receptor III agonist, Poly IC:LC, into and around the tumor to activate the body’s immune defenses, and 4) tumor ablation to reduce production of tumor promoting and immunosuppressive factors. This sequence is referred to as the “Prime”. Patients are then subject to systemic administration of the immune adjuvant to “Boost” the anti-tumor immune response. A full description is available at clinicaltrials.gov Protocol ID NCT00553683





Inclusion Criteria:
1. Over 18 years of age2.
2. Histologically confirmed hepatocellular or metastatic pancreatic carcinoma
3. Radiologically measurable primary, recurrent or metastatic disease confined to the liver.
4. Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occassional help from others).
5. Normal hematologic, renal and liver function (i.e. Absolute neutrophil count > 1500/mm3, Platelets > 75,000/mm3, creatinine ≤ 1.7 mg/dl, total bilirubin ≤ 1.5 mg/dl, transaminases ≤ 3 times above the upper limits of the institutional normal, INR < 1.5.
6. Must be able to provide written informed consent.
7. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. While animal testing has been negative, the anti-proliferative activity of poly IC may theoretically be harmful to the developing fetus or nursing infantExclusion Criteria

Exclusion Criteria:
1. Serious concurrent infections or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety.
2. Left ventricular ejection fraction <50%
3. Pregnancy or breast-feeding. The anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant.
4. Primary or recurrent disease that can be surgically resected leaving the patient disease-free

Contact our study research associate Ismael Castaneda MD at 973-972-6812 or call myself at 973-972-0607 for more information