Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer

Completed · Phase 1

Conditions studied: Adenocarcinoma of the Colon, Adenocarcinoma of the Gallbladder, Adenocarcinoma of the Pancreas, Adenocarcinoma of the Rectum, Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Cholangiocarcinoma of the Gallbladder, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Male Breast Cancer, Mixed Adenocarcinoma of the Stomach, Ovarian Endometrioid Adenocarcinoma, Paget Disease of the Breast With Intraductal Carcinoma, Paget Disease of the Breast With Invasive Ductal Carcinoma, Recurrent Adult Primary Liver Cancer, Recurrent Breast Cancer, Recurrent Colon Cancer, Recurrent Gallbladder Cancer, Recurrent Gastric Cancer, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Pancreatic Cancer, Recurrent Rectal Cancer, Recurrent Salivary Gland Cancer, Salivary Gland Adenocarcinoma, Stage II Malignant Testicular Germ Cell Tumor, Stage II Pancreatic Cancer, Stage III Colon Cancer, Stage III Gastric Cancer, Stage III Malignant Testicular Germ Cell Tumor, Stage III Pancreatic Cancer, Stage III Rectal Cancer, Stage III Salivary Gland Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer, Stage IV Colon Cancer, Stage IV Gastric Cancer, Stage IV Pancreatic Cancer, Stage IV Rectal Cancer, Stage IV Salivary Gland Cancer, Thyroid Gland Medullary Carcinoma, Unresectable Gallbladder Cancer

In brief

Phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have advanced or metastatic cancer. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make tumor cells more sensitive to the vaccine and may kill more tumor cells

Key facts

Study ID

NCT00028496

Run by

National Cancer Institute (NCI)

People needed

48

Starts

2001-11-01

Last updated by the study team

2013-01-25

Who can join

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

You may qualify if…

• Histologically confirmed adenocarcinoma that failed standard curative options and for which no standard palliative options are required within the next 8weeks
• Advanced or metastatic disease
• Recurrent or unresectable disease
• Microscopic metastatic disease confirmed by surgical exploration allowed
• CEA expression by immunohistochemistry
• Circulating CEA greater than 5 ng/mL
• HLA phenotyping required
• HLA phenotyping must be repeated for patients who have undergone allogeneic bone marrow transplantation
• No clinically symptomatic brain metastases
• Patients with brain metastases who have completed palliative radiotherapy and have discontinued steroids are eligible
• Hormone receptor status:
• Not specified
• Male or female
• Performance status - ECOG 0-1
• WBC at least 3,000/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin less than 1.5 times upper limit of normal (ULN)
• AST and ALT less than 3 times ULN
• PT and PTT less than 1.5 times ULN (unless therapeutically anticoagulated)
• Creatinine less than 1.5 mg/dL
• Creatinine clearance greater than 60 mL/min
• Proteinuria or hematuria less than +2 on urinalysis*
• Urine protein less than 1,000 mg/24-hour collection, if proteinuria greater than +1
• No frequent vomiting or severe anorexia
• No more than 10% weight loss within the past 3 months

Where it is running

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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