A Phase I/II Study With CEA(6D) VRP Vaccine in Patients With Advanced or Metastatic CEA-Expressing Malignancies

Completed · Phase 1/Phase 2

Conditions studied: Colorectal Cancer, Breast Cancer, Lung Cancer, Pancreatic Cancer, Colon Cancer

In brief

STUDY OBJECTIVES 1. The primary objective of this protocol is to determine the safety of immunization with CEA(6D) VRP in patients with advanced or metastatic CEA expressing malignancies. 2. The secondary objectives are to evaluate CEA-specific immune response to the immunizations and obtain preliminary data on response rate.

Key facts

Study ID

NCT00529984

Run by

AlphaVax, Inc.

People needed

28

Starts

2007-09-01

Expected to finish

2010-05-01

Last updated by the study team

2012-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cohorts 1-4 only:
• Histologically confirmed diagnosis of metastatic malignancy due to a tumor expressing CEA.
• The tumor must express CEA as defined by immunohistochemical staining, CEA blood level, or a tumor known to be universally CEA positive.
• Must have received treatment with standard therapy having a possible overall survival benefit or refused such therapy.
• Must have received and progressed through at least one line of palliative chemotherapy for colorectal, breast, lung, or pancreatic cancer. For other malignancies, if a first line therapy with survival or palliative benefit exists, it should have been administered and there should have been progressive disease.
• Cohort 5 Only:
• Histologically confirmed colon cancer (rectal cancer excluded). Since colon cancer is nearly universally CEA positive, CEA staining is not required.
• Documented stage III colon cancer with no evidence of disease.
• One to six months following standard post-operative adjuvant treatment, which should have consisted of 5-fluorouracil and folinic acid or capecitabine with or without oxaliplatin for 4-6 months)
• All Cohorts:
• Karnofsky performance status ≥ 70%.
• Estimated life expectancy > 6 months and not expected to require further systemic chemotherapy for at least 3 months.
• Age ≥ 18 years.
• Adequate hematologic function (WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/microliter).
• Adequate renal and hepatic function, (serum creatinine < 1.5 mg/dL, bilirubin ≤ 1.5 mg/dL, and ALT and AST ≤ 2.5 x upper limit of normal).
• Patients who have received CEA-targeted immunotherapy, if treatment was discontinued at least 3 months before enrollment.
• Patients who are taking medications that do not have a known history of immunosuppression are eligible for this trial.
• Ability to understand and provide signed informed consent.
• Ability to return to Duke University Medical Center for adequate follow-up, as required by protocol.

You may not qualify if…

• Concurrent cytotoxic chemotherapy or radiation therapy (must be at least 3 months between any prior CEA-targeted immunotherapy and study treatment and at least 4 weeks between any other prior therapy and study treatment).
• Patients with previously resected brain metastases will be permitted if a CT or MRI scan shows no metastasis within 1 month before enrollment.
• History of autoimmune disease.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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