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

Summary

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

Conditions

• 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

Interventions

BIOLOGICAL

recombinant fowlpox-CEA(6D)/TRICOM vaccine

Given intradermally

BIOLOGICAL

sargramostim

Given subcutaneously

BIOLOGICAL

recombinant fowlpox GM-CSF vaccine adjuvant

Given intradermally

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Margaret von Mehren · Fox Chase Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-11-30

Primary Completion

2005-11-30

Countries

• United States

Study Locations