Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088933
Status:
TERMINATED
Last Update Posted:
2014-03-31
First Post:
2004-08-04
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:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Single Institution Pilot Study of Vaccinia-CEA6D-TRICOM and Fowlpox-CEA6D-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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA051008 | NIH | CTEP | httpsreporternihgovquickSearchP30CA051008 |
| NCI-2009-00049 | REGISTRY | None | None |
| CDR0000377574 | None | None | None |
| 02-452 | None | None | None |
| 02-452 | OTHER | None | None |
| 6230 | OTHER | None | None |
| R01CA088972 | NIH | None | None |