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

Phase 1
18 Years
80 Years
Open (Enrolling)
Metastatic Colorectal Cancer

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Trial Information

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

Dendritic cell (DC)-based vaccination, usually administered by a traditional intradermal
route, is a new treatment option for cancer patients. While the previous DC-based
vaccination trials have shown the safety of this approach and its ability to induce
objective clinical responses, the overall efficacy of DC-based vaccines is still
disappointing (Rosenberg et al., 2004). We hypothesize that the two likely causes of such
limited clinical activity are: A) suboptimal type of DCs used as a vaccine and B) suboptimal
modes of use of such vaccines that do not allow the vaccinated patients to fully benefit
from DC biology.

We will conduct a pilot evaluation of the therapeutic vaccination with DC1s loaded with
autologous tumor material, in patients with metastatic colorectal cancer that have been
resected to no or minimal evidence of disease.The proposed evaluation of the novel
intralymphatic route of DC-based vaccination will allow us to administer the vaccine in a
way that is more physiologic with respect to the kinetics of antigen appearance to the lymph
nodes and is feasible to be performed in repetitive fashion, without damaging local lymph

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/┬Ál, 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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

The primary endpoint of this study is to evaluate the feasibility and safety of semi-continuous intralymphatic vaccination dendritic cells.

Outcome Time Frame:

4 to 14 weeks

Safety Issue:


Principal Investigator

David L. Bartlett, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

January 2008

Completion Date:

July 2014

Related Keywords:

  • Metastatic Colorectal Cancer
  • colorectal
  • cancer
  • vaccine
  • isolated hepatic metastases
  • Colorectal Neoplasms



University of Cancer Institute Pittsburgh, Pennsylvania  15232