Extensive Stage Small Cell Lung CancerPhase 1NCT00088933
Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer
A Phase 1 study testing recombinant fowlpox-CEA(6D)/TRICOM vaccine, recombinant vaccinia-CEA(6D)-TRICOM vaccine and docetaxel in people with Extensive Stage Small Cell Lung Cancer and Recurrent Colon Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer, Recurrent Colon Cancer, Recurrent Non-small Cell Lung Cancer
- What is being tested?
- recombinant fowlpox-CEA(6D)/TRICOM vaccine, recombinant vaccinia-CEA(6D)-TRICOM vaccine and docetaxel
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Nov 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed lung OR colorectal cancer
- Incurable metastatic disease
- Currently available standard treatment not likely to offer a survival advantage or result in superior palliation
- Evaluable disease by radiograph
- Tumor must currently express carcinoembryonic antigen (CEA) by immunohistochemistry OR CEA >= 10 ng/mL at any point during disease course
- No clinically active brain metastases
Show all 65Show fewer
- Must have had first- and second-line treatment OR declined second-line treatment (part I only)
- Patients with colon cancer must have had or have been offered treatment with oxaliplatin (part I only)
- ECOG 0-1
- Life expectancy of at least 4 months
- Absolute neutrophil count >= 1,500/mm^3
- WBC >= 3,000/mm^3
- Platelet count >= 100,000/mm^3
- Bilirubin normal
- Meets 1 of the following criteria:
- SGOT and SGPT =< 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal
- SGOT and SGPT =< normal AND alkaline phosphatase =<4.0 times ULN
- Hepatitis B and C negative by clinical history and physical exam
- Creatinine =< 1.5 mg/dL OR creatinine clearance >= 60 mL/min
- Proteinuria =< grade 1
- No known or suspected history of impaired cardiac function as evidenced by baseline echocardiogram
- Adequate pulmonary function
- No history or clinical evidence of immune deficiency or autoimmunity
- HIV negative
- No history of or concurrent diagnosis of any of the following:
- Altered immunodeficiency
- Eczema or other eczematoid skin disorders
- Acute, chronic, or exfoliative skin condition (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
- No history of allergy or untoward reaction to prior vaccination with vaccinia virus
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No history of allergy to eggs or egg products
- No frequent vomiting or severe anorexia
- No inflammatory bowel disease
- No Crohn's disease
- No ulcerative colitis
- No active diverticulitis
- Neuropathy =< grade 1 (sensory neuropathy)
- No uncontrolled seizure disorder
- No encephalitis
- No multiple sclerosis
- Must be maintaining a reasonable state of nutrition (=< 10 % weight loss in the past month)
- Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with individuals with active or a history of eczema or other eczematoid skin disorders
- Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with those with unresolved acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
- Must be able to avoid close household contact (defined as sharing housing or having close physical contact) for at least 3 weeks after recombinant vaccinia vaccination with any of the following individuals: pregnant or nursing women; children =< 5 years of age; immunodeficient or immunosuppressed individuals (by disease or therapy), including HIV infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 6 months after study participation
- No other concurrent serious medical illness that would preclude study participation
- No concurrent biologic therapy
- No other concurrent immunotherapy
- At least 6 weeks since prior nitrosoureas or mitomycin
- Prior docetaxel allowed (part I only)
- No prior docetaxel (part II only)
- No other concurrent chemotherapy
- No concurrent systemic steroids except for the following:
- physiologic doses for systemic steroid replacement therapy
- local (topical, nasal, or inhaled) steroid use
- no concurrent steroid eye drops
- premedication prior to and after docetaxel
- No concurrent hormonal therapy
- No prior radiotherapy to > 50 % of all nodal groups
- More than 21 days since prior major surgery
- No prior splenectomy
- Recovered from prior therapy
- At least 3-4 weeks since prior cytotoxic therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lombardi Comprehensive Cancer Center at Georgetown University
Washington D.C., District of Columbia, 20057
About this study
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
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.
Read the detailed description
OBJECTIVES:
- 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.
- Conditions
- Extensive Stage Small Cell Lung Cancer, Recurrent Colon Cancer, Recurrent Non-small Cell Lung Cancer, Recurrent Rectal Cancer, Recurrent Small Cell Lung Cancer, Stage IV Colon Cancer
- Being tested
- recombinant fowlpox-CEA(6D)/TRICOM vaccine, recombinant vaccinia-CEA(6D)-TRICOM vaccine, docetaxel, sargramostim
- Medical subject headings
- Colonic Neoplasms, Carcinoma, Non-Small-Cell Lung, Rectal Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant fowlpox-CEA(6D)/TRICOM vaccineDrug
Also called fowlpox-CEA-B7-1/ICAM-1/LFA-3, rF-CEA(6D)TRICOM
Given intradermally
recombinant vaccinia-CEA(6D)-TRICOM vaccineDrug
Also called rV-CEA(6D)-TRICOM
Given intradermally
docetaxelDrug
Also called RP 56976, Taxotere, TXT
Given IV
sargramostimDrug
Also called GM-CSF, Leukine, Prokine
Given subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | 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. Receives: Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine; Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine; Drug: sargramostim |
| Arm II | Experimental | 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. Receives: Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine; Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine; Drug: docetaxel; Drug: sargramostim |
| Arm III | Experimental | 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. Receives: Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine; Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine; Drug: docetaxel; Drug: sargramostim |
| Arm IV | Experimental | Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and full-dose docetaxel IV over 1 hour on day 1. Receives: Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine; Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine; Drug: docetaxel; Drug: sargramostim |
| Arm V | Experimental | 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. Receives: Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine; Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine; Drug: docetaxel; Drug: sargramostim |
| Arm VI | Experimental | 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. Receives: Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine; Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine; Drug: docetaxel; Drug: sargramostim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Up to 6 years
Number of patients experiencing each of the toxicities by grade for each treatment arm
Measured: Up to 6 years
Secondary outcomes (1)
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.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startJun 2004
- Primary completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John Marshall, Principal investigator, Lombardi Comprehensive Cancer Center at Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088933
- Sponsor's protocol ID
- NCI-2009-00049
- Other IDs
- NCI-2009-00049, CDR0000377574, 02-452, 02-452, 6230, R01CA088972, P30CA051008
- Status last verified
- Mar 2013
- First submitted
- 4 Aug 2004
- Last updated
- 31 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00088933
- Acronym / sponsor ID
- NCI-2009-00049
- Conditions
- Extensive Stage Small Cell Lung Cancer, Recurrent Colon Cancer, Recurrent Non-small Cell Lung Cancer, Recurrent Rectal Cancer, Recurrent Small Cell Lung Cancer, Stage IV Colon Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2004
- Primary completion
- Nov 2007 (actual)
- First posted
- 5 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine, Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine, Drug: sargramostimThree 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 | Experimental | Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine, Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine, Drug: docetaxel, Drug: sargramostimPatients 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 | Experimental | Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine, Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine, Drug: docetaxel, Drug: sargramostimPatients 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. |
| Arm IV | Experimental | Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine, Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine, Drug: docetaxel, Drug: sargramostimPatients 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 | Experimental | Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine, Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine, Drug: docetaxel, Drug: sargramostimPatients 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 | Experimental | Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine, Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine, Drug: docetaxel, Drug: sargramostimPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (65 listed)
- Histologically confirmed lung OR colorectal cancer
- Incurable metastatic disease
- Currently available standard treatment not likely to offer a survival advantage or result in superior palliation
- Evaluable disease by radiograph
- Tumor must currently express carcinoembryonic antigen (CEA) by immunohistochemistry OR CEA >= 10 ng/mL at any point during disease course
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant fowlpox-CEA(6D)/TRICOM vaccineAlso: fowlpox-CEA-B7-1/ICAM-1/LFA-3, rF-CEA(6D)TRICOMGiven intradermally | Drug | Arm I, Arm II, Arm III, Arm IV, Arm V, Arm VI |
| recombinant vaccinia-CEA(6D)-TRICOM vaccineAlso: rV-CEA(6D)-TRICOMGiven intradermally | Drug | Arm I, Arm II, Arm III, Arm IV, Arm V, Arm VI |
| docetaxelAlso: RP 56976, Taxotere, TXTGiven IV | Drug | Arm II, Arm III, Arm IV, Arm V, Arm VI |
| sargramostimAlso: GM-CSF, Leukine, ProkineGiven subcutaneously | Drug | Arm I, Arm II, Arm III, Arm IV, Arm V, Arm VI |
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
1 secondary outcome
Average quantity of circulating CEA cells determined by quantitative real time RT-PCR
Time frame: Up to 6 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Marshall principal investigator
Lombardi Comprehensive Cancer Center at Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant fowlpox-CEA(6D)/TRICOM vaccine, recombinant vaccinia-CEA(6D)-TRICOM vaccine and docetaxel in people with Extensive Stage Small Cell Lung Cancer and Recurrent Colon Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 65 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2014.