Clinical Trials Directory

Trials / Completed

CompletedNCT00028496

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

Phase I Study of a Recombinant Fowl Pox Vaccine rF-CEA (6D)/TRICOM Alone or With GM-CSF in Patients With Advanced CEA Expressing Adenocarinomas

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
48 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALrecombinant fowlpox-CEA(6D)/TRICOM vaccineGiven intradermally
BIOLOGICALsargramostimGiven subcutaneously
BIOLOGICALrecombinant fowlpox GM-CSF vaccine adjuvantGiven intradermally

Timeline

Start date
2001-11-01
Primary completion
2005-11-01
First posted
2003-01-27
Last updated
2013-01-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00028496. Inclusion in this directory is not an endorsement.