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2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT00088933
Status:
TERMINATED
Last Update Posted:
2014-03-31
First Post:
2004-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
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 Cancers
Status:
TERMINATED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-00049 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000377574 | None | None | View | |
| 02-452 | None | None | View | |
| 02-452 | OTHER | Lombardi Comprehensive Cancer Center at Georgetown University | View | |
| 6230 | OTHER | CTEP | View | |
| R01CA088972 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA051008 | NIH | None | https://reporter.nih.gov/quic… | View |