Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer (NCT00027534) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
United States14 participantsStarted 2002-01
Plain-language summary
RATIONALE: Vaccines made from a person's white blood cells that have been treated in the laboratory may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* 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
PATIENT CHARACTERISTICS:
Age
* 18 and over Sex
* Male or female Menopausal status
* Not specified Performance status
* Karnofsky 70-100% Life expectancy
* More than 6 months
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute lymphocyte count at least 1,000/mm\^3
* Platelet count at least 100,0…