Phase I Evaluation of Semi-continuous Alpha-type-1 Dendritic Cell-based Vaccines in Patients With Metastatic Colorectal Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed metastatic colorectal cancer with minimal
evidence of disease or resectable metastases (to include extra-hepatic metastases).

- Availability of metastatic tumor material, from hepatic metastasis and additional
sites, that can be resected under sterile conditions for autologous vaccine
preparation (not all tumors harvested will be of sufficient quantity or quality to
make vaccine, therefore some subjects may not receive vaccine).

- No chemotherapy, radiotherapy, major surgery, or biologic therapy for their
malignancy in the 4 weeks prior to the vaccine administration and must have recovered
from all side effects.

- An ECOG performance standard of 0, 1 or 2.

- Adequate hepatic function as evidenced by bilirubin < 2.0 mg/dL and a PT < 2 seconds
of the upper limit of normal.

- Age equal to 18 years or older and greater than 30 kg.

- Platelet counts greater than 100,000, a hematocrit > 27.0, a white blood count >
3000/µl, and a creatinine less than or equal to 1.5 mg/dL or a creatinine clearance
of > 60 mL/min.

- Aware of the neoplastic nature of his/her illness, the experimental nature of the
therapy, alternative treatments, potential benefits and risks, and willing to sign an
informed consent.

- Patients must be able to understand and be willing to sign a written informed consent
document.

Exclusion Criteria:

- Subjects currently treated with systemic immunosuppressive agents, including
steroids, are ineligible until 4 weeks after removal from immunosuppressive
treatment. Subjects on maintenance steroids because of adrenal insufficiency are
eligible.

- Subjects with severely abnormal liver function tests [AST (SGOT), ALT (SGPT), GGT,
Alk.Phos, LDH, and total bilirubin greater than 2 X ULN]

- Subjects with uncontrolled pain.

- Subjects with active autoimmune disease, positive serology for HIV, HBV, or HCV
(testing will be performed with FDA licensed blood donor tests).

- Subjects with concurrent additional malignancy (with exception of non-melanoma skin
cancers and carcinoma in situ of the cervix).

- Subjects who are allergic to or develop an allergy to heparin.

- Subjects who are pregnant.

- Subjects who have sensitivity to drugs that provide local anesthesia.