Clinical Trial: Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Randomized Single Institution Pilot Study of Vaccinia-CEA(6D)-TRICOM and Fowlpox-CEA(6D)-TRICOM With GM-CSF in Combination With Docetaxel in Patients With CEA-Bearing Canc

Brief Summary: This randomized phase I trial studies the side effects, best way to give, and best dose of docetaxel when given together with vaccine therapy and sargramostim in treating patients with metastatic lung cancer or metastatic colorectal cancer. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow and peripheral blood. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy and sargramostim with docetaxel may kill more tumor cells.

Detailed Summary:

OBJECTIVES:

I. Determine the recommended dose and schedule of docetaxel when given in combination with recombinant vaccinia-CEA-TRICOM vaccine, recombinant fowlpox-CEA-TRICOM vaccine, and sargramostim (GM-CSF), defined by best immune response with acceptable toxicity, in patients with carcinoembryonic antigen (CEA)-expressing metastatic lung or colorectal cancer.

II. Compare the effect of varying doses and schedules of docetaxel on CEA-specific T-cell immune responses by ELISPOT assay in patients treated with these regimens.

III. Compare objective antitumor response in patients treated with these regimens.

OUTLINE:

This is a 2-part, randomized, pilot study. Patients are randomized to 1 of 6 treatment arms: arms I, II, and III in part I (lung cancer and colorectal cancer patients) and arms IV, V, and VI in part II (lung cancer patients only). Patients are stratified according to disease site and HLA-A2 positivity (positive vs negative). At least 6 of 10 patients must be HLA-A2 positive for each of the treatment arms.

Vaccinia-CEA-TRICOM vaccine (parts I and II): In all treatment arms, patients receive vaccinia-CEA-TRICOM vaccine intradermally on day 1 and sargramostim (GM-CSF) subcutaneously (SC) into the vaccine site on days 1-4.

Fowlpox-CEA-TRICOM vaccine and concurrent chemotherapy:

Part I (lung cancer and colorectal cancer patients):

ARM 1: Three weeks after treatment with vaccinia-CEA-TRICOM vaccine, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC into e
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Anti-tumor response rate defined as the number of patients in each arm achieving a complete or partial response or stable disease divided by the total number of patients on each arm measured according to standard RECIST guidelines [ Time Frame: Up to 6 years ]
  • Immune response defined as the numbers of patients who achieve an ELISPOT result of 1/30,000 or higher divided by the number of HLA-A2 positive individuals for each treatment arm [ Time Frame: Up to 6 years ]
    The actual ELISPOT will be recorded for each individual and will be presented graphically.
  • Number of patients experiencing each of the toxicities by grade for each treatment arm [ Time Frame: Up to 6 years ]


Original Primary Outcome:

Current Secondary Outcome: Average quantity of circulating CEA cells determined by quantitative real time RT-PCR [ Time Frame: Up to 6 years ]

The impact of the combination therapy on CCC will be presented graphically with descriptive statistics. Will be plotted for each time point by each treatment group.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 4, 2004
Date Started: June 2004
Date Completion:
Last Updated: March 28, 2014
Last Verified: March 2013