A Phase 1 interventional study of recombinant fowlpox-CEA(6D)/TRICOM vaccine and recombinant vaccinia-CEA(6D)-TRICOM vaccine in Extensive Stage Small Cell Lung Cancer, Recurrent Colon Cancer and Recurrent Non-small Cell Lung Cancer, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-31.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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.
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 each vaccination site on days 1-4.
ARM II: Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and lower-dose docetaxel IV over 30 minutes on days 1 and 8.
ARM III: Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and standard-dose docetaxel IV over 30 minutes on days 1 and 8.
Part II (lung cancer patients only):
ARM IV: Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and full-dose docetaxel IV over 1 hour on day 1.
ARM V: Patients receive full-dose docetaxel IV over 1 hour on day 1, fowlpox-CEA-TRICOM vaccine SC on day 8, and GM-CSF SC into each vaccination site on days 8-11.
ARM VI: Patients receive full-dose docetaxel as in arm V, fowlpox-CEA-TRICOM vaccine SC on day 15, and GM-CSF SC into each vaccination site on days 15-18.
Treatment in all arms repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Patients who do not have significant disease progression or unacceptable toxicity after 4 courses of treatment may receive additional fowlpox-CEA-TRICOM vaccine and docetaxel according to the treatment arm on which they were enrolled at study entry. Patients are followed every 6 months for 2 years and then annually for 13 years.
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
This study's enrollment of 60 is below the median of 89 across 1,067 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.
Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Meets 1 of the following criteria:
No history of or concurrent diagnosis of any of the following:
No concurrent systemic steroids except for the following:
Three weeks after treatment with vaccinia-CEA-TRICOM vaccine, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC into each vaccination site on days 1-4.
Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine · Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine · Drug: sargramostim
Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and lower-dose docetaxel IV over 30 minutes on days 1 and 8.
Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine · Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine · Drug: docetaxel · Drug: sargramostim
Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and standard-dose docetaxel IV over 30 minutes on days 1 and 8.
Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine · Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine · Drug: docetaxel · Drug: sargramostim
Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and full-dose docetaxel IV over 1 hour on day 1.
Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine · Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine · Drug: docetaxel · Drug: sargramostim
Patients receive full-dose docetaxel IV over 1 hour on day 1, fowlpox-CEA-TRICOM vaccine SC on day 8, and GM-CSF SC into each vaccination site on days 8-11.
Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine · Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine · Drug: docetaxel · Drug: sargramostim
Patients receive full-dose docetaxel as in arm V, fowlpox-CEA-TRICOM vaccine SC on day 15, and GM-CSF SC into each vaccination site on days 15-18.
Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine · Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine · Drug: docetaxel · Drug: sargramostim
Drug page: Recombinant Fowlpox-CEA(6D)/TRICOM Vaccine
Given intradermally
Also known as: fowlpox-CEA-B7-1/ICAM-1/LFA-3, rF-CEA(6D)TRICOM
Given intradermally
Also known as: rV-CEA(6D)-TRICOM
Given IV
Also known as: RP 56976, Taxotere, TXT
Given subcutaneously
Also known as: GM-CSF, Leukine, Prokine
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
The actual ELISPOT will be recorded for each individual and will be presented graphically.
Time frame: Up to 6 years
Number of patients experiencing each of the toxicities by grade for each treatment arm
Time frame: Up to 6 years
Average quantity of circulating CEA cells determined by quantitative real time RT-PCR
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.
Time frame: Up to 6 years
This study is terminated, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Docetaxel
National Cancer Institute (NCI) →