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Chemotherapy
Vaccine + Chemotherapy for Colorectal Cancer
Phase 2
Waitlist Available
Research Sponsored by Herbert Irving Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance status ECOG 0-1
Age 18 and over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well giving tetanus toxoid together with chemotherapy and vaccine therapy works in treating patients with metastatic colorectal cancer.
Who is the study for?
Adults over 18 with metastatic colorectal cancer can join this trial if they haven't had chemotherapy for metastasis, have a life expectancy over 6 months, and are generally healthy. They must not be immunocompromised, pregnant or nursing, and should agree to use contraception during the study.Check my eligibility
What is being tested?
The trial is testing how well patients respond to vaccine therapy combined with chemotherapy versus chemotherapy alone. Some will also receive tetanus toxoid to see if it enhances treatment effectiveness. Participants are randomly assigned to these groups.See study design
What are the potential side effects?
Possible side effects include typical reactions from vaccines like soreness or fever, as well as those from chemotherapy such as nausea, fatigue, hair loss, increased risk of infection and organ-specific issues depending on individual health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am 18 years old or older.
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My lung condition is under control and not worsening.
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My cancer is a type of colorectal cancer that has spread.
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I do not have active brain metastases.
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I don't have ongoing major bowel issues or chronic diarrhea.
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My heart condition is stable with no uncontrolled issues.
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My creatinine level is below 2.5 mg/dL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
Herbert Irving Comprehensive Cancer CenterLead Sponsor
33 Previous Clinical Trials
929 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,153 Total Patients Enrolled
Howard L. Kaufman, MDStudy ChairHerbert Irving Comprehensive Cancer Center
3 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I do not have HIV, autoimmune diseases, allergies to egg or neomycin, and no bad reactions to tetanus vaccines.I haven't had radiotherapy on more than half of my lymph nodes and no current radiotherapy affecting my bone marrow.I am 18 years old or older.My lung condition is under control and not worsening.My liver function tests are within the required limits and I don't have liver cirrhosis.My cancer is a type of colorectal cancer that has spread.I do not have active brain metastases.I don't have ongoing major bowel issues or chronic diarrhea.I have not had CEA-targeted immunotherapy or any other immunotherapy at the same time.I haven't had a major organ transplant and have recovered from any previous surgeries.It's been over 6 months since my last chemotherapy for early-stage cancer, and I haven't had chemo for advanced cancer.I am not taking daily steroids or hormone therapy that isn't for replacement.My heart condition is stable with no uncontrolled issues.My creatinine level is below 2.5 mg/dL.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment currently have room for new participants?
"According to the latest information found on clinicaltrials.gov, this study is not currently looking for new participants. Although it was last updated over 6 years ago, this trial was originally posted on December 1st, 2001. There are 1112 other trials that are actively recruiting patients right now."
Answered by AI
Are Canadian medical facilities testing this treatment?
"13 hospitals are running this study currently, with locations in Scranton, Birmingham, Tampa and elsewhere. To cut down on travel time and hassle, patients are encouraged to enroll at the location nearest them."
Answered by AI
What risks are associated with this line of treatment?
"While there is some data indicating this treatment may be safe, it remains unproven whether or not it is effective. For that reason, we've given it a rating of 2."
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