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Clinical Trial 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


Clinical Trial Description

PRIMARY OBJECTIVES:

I. Determine the toxicity of recombinant fowlpox-CEA-TRICOM vaccine with or without sargramostim (GM-CSF) or recombinant fowlpox-GM-CSF in patients with advanced or metastatic CEA-expressing adenocarcinomas.

II. Determine the CEA-specific T-cell precursor frequency in patients treated with these regimens.

III. Assess the immunogenicity of GM-CSF in patients treated with these regimens.

IV. Determine the inflammatory response and cytokine expression at the vaccination site in these patients 48 hours after vaccination.

V. Correlate telomere length of leukocytes with prior cytotoxic therapies and immunologic response in patients treated with these regimens.

OUTLINE: This is a dose-escalation study. The first three cohorts of 3-12 patients receive escalating doses of recombinant fowlpox-CEA-TRICOM vaccine (fCEA-TRI) until the maximum tolerated dose (MTD) is determined.

The MTD is defined as the dose preceding that at which 2 of 6 patients or 3 of 12 patients experience dose-limiting toxicity. fCEA-TRI is administered intradermally every 2 weeks for 4 doses and then every 2 months thereafter (beginning on day 56) in the absence of disease progression or unacceptable toxicity.

The fourth and fifth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of sargramostim (GM-CSF). GM-CSF is administered subcutaneously once daily beginning on the day of each vaccination and continuing for a total of 4 days.

The sixth through eighth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of recombinant fowlpox-GM-CSF (rF-GM-CSF). rF-GM-CSF is administered in the same manner as GM-CSF.

Patients are followed every month for 4 months. ;


Study Design

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


Related Conditions & MeSH terms

  • Adenocarcinoma
  • 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
  • Breast Diseases
  • Breast Neoplasms
  • Breast Neoplasms, Male
  • Carcinoma
  • Carcinoma, Ductal
  • Carcinoma, Endometrioid
  • Carcinoma, Hepatocellular
  • Carcinoma, Intraductal, Noninfiltrating
  • Cholangiocarcinoma
  • Cholangiocarcinoma of the Gallbladder
  • Diffuse Adenocarcinoma of the Stomach
  • Gallbladder Neoplasms
  • Intestinal Adenocarcinoma of the Stomach
  • Liver Neoplasms
  • Male Breast Cancer
  • Mixed Adenocarcinoma of the Stomach
  • Neoplasms, Germ Cell and Embryonal
  • Ovarian Endometrioid Adenocarcinoma
  • Paget Disease of the Breast With Intraductal Carcinoma
  • Paget Disease of the Breast With Invasive Ductal Carcinoma
  • Pancreatic Neoplasms
  • Rectal Neoplasms
  • 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
  • Salivary Gland Neoplasms
  • 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
  • Stomach Neoplasms
  • Testicular Neoplasms
  • Thyroid Gland Medullary Carcinoma
  • Thyroid Neoplasms
  • Unresectable Gallbladder Cancer

NCT number NCT00028496
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date November 2001

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