Colorectal CancerPhase 1/2NCT00016133
Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That Has Been Removed During Surgery
A Phase 1/2 study testing BCG vaccine, autologous tumor cell vaccine and fluorouracil in people with Colorectal Cancer, run by Intracel at 2 sites in United States.
Trial summary
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- BCG vaccine, autologous tumor cell vaccine and fluorouracil
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Mar 2001to Aug 2004
- Phase
- Phase 1/2
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed stage II or III primary adenocarcinoma of the colon
- Completely resected within the past 28-35 days, at which time tumor tissue is harvested for vaccine production
- No residual or metastatic disease
- No more than 1 malignant invasive primary colon cancer
- No tumor originating in the rectum (i.e., inferior tumor margin must not be at or below the peritoneal reflection)
- No perforated tumors
PATIENT CHARACTERISTICS:
Age:
- 21 to 85
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 4,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10.0 g/dL
Hepatic:
- Bilirubin normal
- SGOT normal
- Alkaline phosphatase normal
- No severe hepatic disease that would preclude study
Renal:
- Creatinine less than 1.5 times upper limit of normal
- No severe renal disease that would preclude study
Cardiovascular:
- No prosthetic cardiac valves
- No recent vascular prosthesis
- No postsurgical cardiovascular complication
- No severe cardiovascular disease that would preclude study
Pulmonary:
- No postsurgical pulmonary complication
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No insulin-dependent diabetes mellitus
- No severe systemic disease that would preclude study
- No congenital or acquired immune deficiency disease
- No history of chronic ulcerative colitis, Crohn's disease, Gardner's syndrome, or Turcot's syndrome
- No ileus
- No other prior malignancy except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- No ongoing infection requiring systemic antibiotics
- No severe postoperative complication that would preclude study
- Carcinoembryonic antigen normal
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No other concurrent investigational immunotherapy
Chemotherapy:
- No prior systemic chemotherapy
- No other concurrent investigational chemotherapy
Endocrine therapy:
- No concurrent steroids
Radiotherapy:
- No prior radiotherapy
- No concurrent investigational radiotherapy
Surgery:
- See Disease Characteristics
- No concurrent investigational surgery
Other:
- At least 3 weeks since prior systemic antibiotic therapy of more than 5 days duration (excluding topical antibiotics or perioperative prophylactic antibiotics)
- No concurrent cytotoxic immunosuppressive agents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, 18105-1556
Inova Fairfax Hospital
Fairfax, Virginia, 22031
About this study
Official title: A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy combined with leucovorin and fluorouracil in treating patients who have undergone surgery to completely remove stage II or stage III colon cancer.
Read the detailed description
OBJECTIVES:
- Determine safety and immunogenicity of adjuvant autologous tumor cell vaccine in patients with completely resected stage II or III adenocarcinoma of the colon.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II vs III).
Beginning 28-35 days after total surgical resection, patients receive adjuvant autologous tumor cell vaccine intradermally once weekly for 3 vaccinations. The first 2 vaccinations also contain BCG. Patients with stage II disease receive a fourth vaccination 6 months after surgical resection.
Beginning 10-17 days after the third vaccination, patients with stage III disease receive adjuvant leucovorin calcium IV and fluorouracil IV on days 1-5. Chemotherapy continues every 28-35 days for a total of 6 courses. These patients also receive a fourth vaccination 1 month after the completion of chemotherapy.
Patients are followed at 90 days and 6 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- BCG vaccine, autologous tumor cell vaccine, fluorouracil, leucovorin calcium, adjuvant therapy
- Keywords
- stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG vaccineBiological
autologous tumor cell vaccineBiological
fluorouracilDrug
adjuvant therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2001
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Intracel
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael G Hanna Jr., PhD, Study chair, Intracel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016133
- Sponsor's protocol ID
- INTRACEL-ASI-2002
- Other IDs
- CDR0000068597
- Status last verified
- Jul 2004
- First submitted
- 6 May 2001
- Last updated
- 30 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer
- ClinicalTrials.gov ID
- NCT00016133
- Acronym / sponsor ID
- INTRACEL-ASI-2002
- Conditions
- Colorectal Cancer
- Keywords
- stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- IntracelIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Study completion
- Aug 2004 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy combined with leucovorin and fluorouracil in treating patients who have undergone surgery to completely remove stage II or stage III colon cancer.
Detailed description
OBJECTIVES:
- Determine safety and immunogenicity of adjuvant autologous tumor cell vaccine in patients with completely resected stage II or III adenocarcinoma of the colon.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II vs III).
Beginning 28-35 days after total surgical resection, patients receive adjuvant autologous tumor cell vaccine intradermally once weekly for 3 vaccinations. The first 2 vaccinations also contain BCG. Patients with stage II disease receive a fourth vaccination 6 months after surgical resection.
Beginning 10-17 days after the third vaccination, patients with stage III disease receive adjuvant leucovorin calcium IV and fluorouracil IV on days 1-5. Chemotherapy continues every 28-35 days for a total of 6 courses. These patients also receive a fourth vaccination 1 month after the completion of chemotherapy.
Patients are followed at 90 days and 6 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 21 to 85 years
- 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 |
|---|---|---|
| BCG vaccine | Biological | – |
| autologous tumor cell vaccine | Biological | – |
| fluorouracil | Drug | – |
| leucovorin calcium | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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 G Hanna Jr., PhD study chair
Intracel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BCG vaccine, autologous tumor cell vaccine and fluorouracil in people with Colorectal Cancer, run by Intracel at 2 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 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 30 May 2013.