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A Phase I Study Of Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox -Tricom In Patients With Advanced Or Metastatic Malignancies Expressing CEA

Phase 1
18 Years
Not Enrolling
Breast Cancer, Colorectal Cancer, Gallbladder Cancer, Gastric Cancer, Head and Neck Cancer, Liver Cancer, Ovarian Cancer, Pancreatic Cancer, Testicular Germ Cell Tumor

Thank you

Trial Information

A Phase I Study Of Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox -Tricom In Patients With Advanced Or Metastatic Malignancies Expressing CEA


- Determine the safety and feasibility of active immunotherapy comprising autologous
dendritic cells infected with recombinant fowlpox-CEA-TRICOM vaccine in patients with
advanced or metastatic malignancies expressing CEA.

- Assess the CEA-specific immune response of patients treated with this regimen.

- Assess, in a preliminary manner, the clinical response rate of patients treated with
this regimen.

OUTLINE: This is a dose-escalation study.

Autologous dendritic cells (ADCs) are harvested and infected with fowlpox-CEA-TRICOM
vaccine. Patients receive the infected ADCs intradermally and subcutaneously (SC) followed
by ADCs mixed with CMV pp65 peptide and ADCs mixed with tetanus toxoid SC and intradermally
on day 1. Treatment repeats every 3 weeks for a total of 4, 8, or 12 immunizations in the
absence of unacceptable toxicity.

Cohorts of 6 patients receive an escalating number of immunizations until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed advanced or metastatic malignancy expressing CEA

- Metastatic disease meeting one of the following criteria:

- Measurable or nonmeasurable

- History of metastases but no current evidence of disease, meeting one of
the following criteria:

- Unresectable peritoneal or lymph node metastases that cannot be
detected by imaging

- Treated or resected metastatic disease considered at high risk of
recurrence (predicted 5-year disease-free survival of less than 50%)

- Must have completed treatment that rendered no evidence of
disease within the past year

- CEA-expressing malignancy is defined by any of the following:

- Immunohistochemical staining (at least 50% of the tumor has at least a moderate
intensity of staining)

- CEA level in peripheral blood greater than 2.5 µg/L

- Tumor known to be universally CEA positive (e.g., colon and rectal cancer)

- Received prior therapy with possible survival benefit or refused such therapy

- Prior resection of brain metastases allowed provided no metastasis by CT scan or MRI
of the brain within 1 month of enrollment

- Hormone receptor status:

- Not specified



- 18 and over Sex

- Male or female Menopausal status

- Not specified Performance status

- Karnofsky 70-100% Life expectancy

- More than 6 months


- WBC at least 3,000/mm^3

- Absolute lymphocyte count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL (transfusion or epoetin alfa allowed) Hepatic

- Bilirubin less than 2.0 mg/dL

- SGOT/SGPT less than 1.5 times upper limit of normal

- No active acute or chronic viral hepatitis

- Hepatitis B surface antigen negative

- Hepatitis C negative

- No other hepatic disease that would preclude study entry


- Creatinine less than 2.5 mg/dL

- No active acute or chronic urinary tract infection


- No New York Heart Association class III or IV heart disease Immunologic

- HIV negative

- No history of autoimmune disease, including, but not limited to, the following:

- Inflammatory bowel disease

- Systemic lupus erythematosus

- Rheumatoid arthritis

- Ankylosing spondylitis

- Scleroderma

- Multiple sclerosis

- No allergy to eggs or any component of study vaccine Other

- No active acute or chronic infection

- No concurrent serious acute or chronic illness that would preclude study entry

- No other medical or psychological impediment that would preclude study entry

- No other malignancy within the past 5 years except nonmelanoma skin cancer,
controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy

- At least 4 weeks since prior biologic therapy and recovered

- No other concurrent immunotherapy


- At least 4 weeks since prior chemotherapy and recovered

- No concurrent chemotherapy

Endocrine therapy

- At least 4 weeks since prior hormonal therapy and recovered

- At least 6 weeks since prior steroids except steroids used as premedication for
chemotherapy or for contrast-enhanced studies

- No concurrent steroids


- Prior palliative radiotherapy (including systemic radiolabeled compounds) for
unstable or painful bone metastases in weight-bearing bones may be allowed

- At least 4 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy


- Not specified


- At least 4 weeks since any other prior therapy (including experimental therapy) and

- No concurrent immunosuppressives (e.g., azathioprine or cyclosporine)

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

The primary objective of this protocol is to determine the safety and feasibility of rF-CEA(6D)-TRICOM loaded DC in, subjects with metastatic, CEA expressing malignancies.

Outcome Time Frame:

12-36 weeks

Safety Issue:


Principal Investigator

Herbert K. Lyerly, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Federal Government

Study ID:

CDR0000069041, 2840



Start Date:

January 2002

Completion Date:

October 2007

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Gallbladder Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Liver Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Testicular Germ Cell Tumor
  • recurrent colon cancer
  • stage III colon cancer
  • stage IV colon cancer
  • recurrent breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • recurrent gastric cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • recurrent pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent rectal cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • recurrent gallbladder cancer
  • unresectable gallbladder cancer
  • thyroid gland medullary carcinoma
  • recurrent salivary gland cancer
  • stage III salivary gland cancer
  • stage IV salivary gland cancer
  • Paget disease of the breast with intraductal carcinoma
  • Paget disease of the breast with invasive ductal carcinoma
  • adult primary hepatocellular carcinoma
  • diffuse adenocarcinoma of the stomach
  • intestinal adenocarcinoma of the stomach
  • mixed adenocarcinoma of the stomach
  • adenocarcinoma of the colon
  • adenocarcinoma of the gallbladder
  • adenocarcinoma of the rectum
  • recurrent malignant testicular germ cell tumor
  • stage II malignant testicular germ cell tumor
  • stage III malignant testicular germ cell tumor
  • male breast cancer
  • adenocarcinoma of the pancreas
  • cholangiocarcinoma of the gallbladder
  • salivary gland adenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • stage IV pancreatic cancer
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Liver Neoplasms
  • Stomach Neoplasms
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Gallbladder Neoplasms
  • Neoplasms, Germ Cell and Embryonal



Duke Comprehensive Cancer Center Durham, North Carolina  27710