Colorectal CancerPhase 2NCT00103142
Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
A Phase 2 study testing falimarev, inalimarev and sargramostim in people with Colorectal Cancer and Metastatic Cancer, run by Michael Morse, MD at 6 sites in United States.
Trial summary
RATIONALE: Vaccines made from a gene-modified virus and a person's white blood cells may make the body build an effective immune response to kill tumor cells. Biological therapies, such as Granulocyte-macrophage colony-stimulating factor (GM-CSF), may stimulate the immune system in different ways and stop tumor cells… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastatic Cancer
- What is being tested?
- falimarev, inalimarev and sargramostim
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2005to Mar 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
DISEASE CHARACTERISTICS:
- Histologically confirmed hepatic or pulmonary metastases secondary to adenocarcinoma of the colon and rectum
- Must have undergone complete resection of hepatic or pulmonary metastases with curative intent
- No evidence of gross residual disease after surgery
- One or more resected and ablated lesions allowed provided all gross residual tumor was destroyed by ablation
- Repeated resections of hepatic metastatic disease or resections of extrahepatic metastases prior to resection of the hepatic metastases allowed provided the most recent hepatic metastatic resection included total disease resection and/or ablation
- Must have received at least 2 months of perioperative systemic chemotherapy (including preoperative and/or postoperative chemotherapy) that was completed at least 1 month ago
PATIENT CHARACTERISTICS:
Age
- At least 18
Performance status
- Karnofsky 70-100%
Life expectancy
- At least 6 months
Hematopoietic
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 8.5 g/dL (transfusion or epoetin alfa allowed)
Hepatic
- Bilirubin ≤ 2.0 mg/dL
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- No other serious chronic or acute hepatic disease
Renal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance > 60 mL/min
Cardiovascular
- No New York Heart Association class III or IV cardiac disease
- No other serious chronic or acute cardiac disease
Pulmonary
- No asthma
- No chronic obstructive pulmonary disease
- No other serious chronic or acute pulmonary disease
Immunologic
- No history of autoimmune disease, including, but not limited to, any of the following:
- Inflammatory bowel disease
- Systemic lupus erythematosus
- Ankylosing spondylitis
- Scleroderma
- Multiple sclerosis
- No human immunodeficiency virus (HIV) infection by enzyme-linked immunosorbent assay (ELISA) and western blot
- Not immunocompromised (by disease or therapy)
- No allergy to eggs or any component of the study vaccine
- No history of allergy or untoward reaction to prior vaccinia (smallpox) vaccination
- No allergy or untoward reaction to sargramostim (GM-CSF)
- No active acute or chronic infection, including urinary tract infection within the past 72 hours
- No inflammatory bowel conditions, including, but not limited to, the following:
- Active infectious enteritis
- Eosinophilic enteritis
- No acute, chronic, or exfoliative skin disorders, including any of the following:
- Extensive psoriasis
- Burns
- Impetigo
- Disseminated zoster
- Varicella zoster
- Severe acne
- Other open rashes or wounds
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to avoid close contact or household contact for 3 weeks after each vaccination with the following individuals:
- Children under 5 years of age
- Pregnant or nursing women
- Individuals with prior or concurrent extensive eczema, other eczematoid skin disorders, or other acute or chronic skin conditions
- Immunosuppressed or immunodeficient individuals
- No medical or psychological condition that would preclude study compliance
- No extensive eczema
- No other serious chronic or acute illness that would preclude study participation
- No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled superficial bladder cancer, or previously treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- No concurrent chemotherapy
Endocrine therapy
- More than 6 weeks since prior and no concurrent steroid therapy
Radiotherapy
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
Other
- No other concurrent immunosuppressants (e.g., azathioprine or cyclosporine)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase II Study of Active Immunotherapy With PANVAC or Autologous, Cultured Dendritic Cells Infected With PANVAC After Complete Resection of Hepatic or Pulmonary Metastases of Colorectal Carcinoma
RATIONALE: Vaccines made from a gene-modified virus and a person's white blood cells may make the body build an effective immune response to kill tumor cells. Biological therapies, such as Granulocyte-macrophage colony-stimulating factor (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing. Combining different types of biological therapies may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying giving vaccine therapy together with dendritic cells to see how well it works compared to giving vaccine therapy together with GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- Compare 2-year disease-free survival of patients with completely resected hepatic or pulmonary metastases secondary to colorectal cancer treated with adjuvant vaccine therapy comprising vaccinia-Carcinoembryonic antigen (CEA)-mucin 1 (MUC-1)- Triad of costimulatory molecules TRICOM vaccine (PANVAC-V) and fowlpox-CEA-MUC-1-TRICOM vaccine (PANVAC-F) administered with autologous dendritic cells or with sargramostim (GM-CSF).
Secondary
- Compare the rate and magnitude of immune response, as determined by enzyme-linked immunosorbent spot (ELISpot), in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneously (SC) and intradermally (ID) on days 28, 56, and 84.
- Arm II: Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
After completion of study treatment, patients are followed for 2 years.
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study within 2 years.
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Being tested
- falimarev, inalimarev, sargramostim, therapeutic autologous dendritic cells
- Keywords
- liver metastases, adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV rectal cancer, lung metastases
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
falimarevBiological
Given subcutaneously and intradermally
inalimarevBiological
Given subcutaneously and intradermally
sargramostimBiological
Given subcutaneously
therapeutic autologous dendritic cellsBiological
Given subcutaneously and intradermally
| Study group | Role | What they receive |
|---|---|---|
| PANVAC-V + PANVAC-F + DC | Experimental | Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84. Receives: Biological: falimarev; Biological: inalimarev; Biological: therapeutic autologous dendritic cells |
| PANVAC-V + PANVAC-F + GM-CSF | Experimental | Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87. Receives: Biological: falimarev; Biological: inalimarev; Biological: sargramostim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free Survival at 2 Years
Recurrence-free survival for randomized patients receiving dendritic cells (DC) loaded with PANVAC or PANVAC plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) measured from the date of metastasectomy, with relapse defined as documented disease recurrence at any site.
Measured: 2 years
Secondary outcomes (1)
Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay
CEA-Specific Immune Responders by enzyme-linked immunosorbent spot (ELISpot). The ELISPOT assay is considered positive for a subject if the mean number of spots with CEA exceeds the number of spots with control by a magnitude of 10 and the difference between CEA and control is statistically significant at a level of p=0.05 by the t-test.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2005 (estimated)
- Study startFeb 2005
- Primary completionJun 2009
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Morse, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Michael Morse, MD, Duke University
- Investigators
- Michael A. Morse, MD, Study chair, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103142
- Sponsor's protocol ID
- Pro00007616
- Other IDs
- DUMC-5883-04-6RO, CDR000041079
- Status last verified
- Oct 2015
- First submitted
- 7 Feb 2005
- Last updated
- 14 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Morse MA, Niedzwiecki D, Marshall JL, Garrett C, Chang DZ, Aklilu M, Crocenzi TS, Cole DJ, Dessureault S, Hobeika AC, Osada T, Onaitis M, Clary BM, Hsu D, Devi GR, Bulusu A, Annechiarico RP, Chadaram V, Clay TM, Lyerly HK. A randomized phase II study of immunization with dendritic cells modified with poxvectors encoding CEA and MUC1 compared with the same poxvectors plus GM-CSF for resected metastatic colorectal cancer. Ann Surg. 2013 Dec;258(6):879-86. doi: 10.1097/SLA.0b013e318292919e.
PubMed 23657083
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Active Immunotherapy With PANVAC or Autologous, Cultured Dendritic Cells Infected With PANVAC After Complete Resection of Hepatic or Pulmonary Metastases of Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00103142
- Acronym / sponsor ID
- Pro00007616
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Keywords
- liver metastases, adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV rectal cancer, lung metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Michael Morse, MDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Feb 2005 (estimated)
- Results
- Posted 7 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Vaccines made from a gene-modified virus and a person's white blood cells may make the body build an effective immune response to kill tumor cells. Biological therapies, such as Granulocyte-macrophage colony-stimulating factor (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing. Combining different types of biological therapies may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying giving vaccine therapy together with dendritic cells to see how well it works compared to giving vaccine therapy together with GM-CSF in treating patients with liver or lung metastases from colorectal cancer removed by surgery.
Detailed description
OBJECTIVES:
Primary
- Compare 2-year disease-free survival of patients with completely resected hepatic or pulmonary metastases secondary to colorectal cancer treated with adjuvant vaccine therapy comprising vaccinia-Carcinoembryonic antigen (CEA)-mucin 1 (MUC-1)- Triad of costimulatory molecules TRICOM vaccine (PANVAC-V) and fowlpox-CEA-MUC-1-TRICOM vaccine (PANVAC-F) administered with autologous dendritic cells or with sargramostim (GM-CSF).
Secondary
- Compare the rate and magnitude of immune response, as determined by enzyme-linked immunosorbent spot (ELISpot), in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneously (SC) and intradermally (ID) on days 28, 56, and 84.
- Arm II: Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
After completion of study treatment, patients are followed for 2 years.
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PANVAC-V + PANVAC-F + DC | Experimental | Biological: falimarev, Biological: inalimarev, Biological: therapeutic autologous dendritic cellsPatients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84. |
| PANVAC-V + PANVAC-F + GM-CSF | Experimental | Biological: falimarev, Biological: inalimarev, Biological: sargramostimPatients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| falimarevGiven subcutaneously and intradermally | Biological | PANVAC-V + PANVAC-F + DC, PANVAC-V + PANVAC-F + GM-CSF |
| inalimarevGiven subcutaneously and intradermally | Biological | PANVAC-V + PANVAC-F + DC, PANVAC-V + PANVAC-F + GM-CSF |
| sargramostimGiven subcutaneously | Biological | PANVAC-V + PANVAC-F + GM-CSF |
| therapeutic autologous dendritic cellsGiven subcutaneously and intradermally | Biological | PANVAC-V + PANVAC-F + DC |
Primary outcome
Recurrence-free Survival at 2 Years
Time frame: 2 years
Recurrence-free survival for randomized patients receiving dendritic cells (DC) loaded with PANVAC or PANVAC plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) measured from the date of metastasectomy, with relapse defined as documented disease recurrence at any site.
1 secondary outcome
Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay
Time frame: 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23657083Morse MA, Niedzwiecki D, Marshall JL, Garrett C, Chang DZ, Aklilu M, Crocenzi TS, Cole DJ, Dessureault S, Hobeika AC, Osada T, Onaitis M, Clary BM, Hsu D, Devi GR, Bulusu A, Annechiarico RP, Chadaram V, Clay TM, Lyerly HK. A randomized phase II study of immunization with dendritic cells modified with poxvectors encoding CEA and MUC1 compared with the same poxvectors plus GM-CSF for resected metastatic colorectal cancer. Ann Surg. 2013 Dec;258(6):879-86. doi: 10.1097/SLA.0b013e318292919e.
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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.
Michael A. Morse, MD study chair
Duke Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing falimarev, inalimarev and sargramostim in people with Colorectal Cancer and Metastatic Cancer, run by Michael Morse, MD at 6 sites 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?
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: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recurrence-free Survival at 2 Years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00103142, which also lists 1 linked publication.
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 14 Oct 2015.