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Cancer Vaccine
Cancer Vaccine + GM-CSF for Myelodysplastic Syndrome
Phase 2
Waitlist Available
Research Sponsored by The Vaccine Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HLA-A2 positive at one allele
Diagnosis of myelodysplastic syndromes (MDS) with specific subtypes (FAB class refractory anemia (RA), RA with excess blasts (RAEB), or RA with ringed sideroblasts (RARS); WHO Classification RA, RARS, refractory cytopenia with multilineage dysplasia (RCMD), RCMD with ringed sideroblasts, or RAEB-1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a cancer vaccine given with GM-CSF to see if it is effective in treating patients with low or intermediate risk myelodysplastic syndrome.
Who is the study for?
This trial is for adults with low or intermediate-risk myelodysplastic syndrome (MDS), a bone marrow disorder. Participants must be relatively healthy, not pregnant, agree to use contraception, and have normal organ function tests. They can't join if they have high-risk MDS, other cancers within the last 5 years (with some exceptions), severe heart or lung disease, HIV/AIDS, recent treatments for MDS or certain infections.Check my eligibility
What is being tested?
The study is testing a vaccine therapy combined with GM-CSF (a substance that boosts white blood cells) to see if it's effective in treating patients with MDS by enhancing their immune response against cancer cells. It's a phase II trial which means it focuses on the treatment’s effectiveness.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site from the vaccine and increased risk of infection due to GM-CSF. Other common issues might involve flu-like symptoms such as fever and chills, fatigue, muscle aches and pains.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am HLA-A2 positive.
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I have been diagnosed with a specific type of MDS.
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I am fully active or can carry out light work.
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I have been diagnosed with MDS, either as a new case or due to previous treatment.
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My blood disorder is at an intermediate-1 stage or I need regular blood transfusions.
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
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immunologic response after four injections of vaccine formulation as determined by an increase in the absolute PR1-HLA-A2 tetramer count by at least 0.5/μl
Secondary outcome measures
Clinical response as determined by modified IWG criteria
Conversion of non-immunologic responders to immunologic responders by administering 4 additional doses of vaccine
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Who is running the clinical trial?
The Vaccine CompanyLead Sponsor
3 Previous Clinical Trials
261 Total Patients Enrolled
Craig S. Rosenfeld, MDStudy ChairThe Vaccine Company
1 Previous Clinical Trials
244 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently fighting a worsening viral or bacterial infection.My condition is RAEB-2 or is transforming from RAEB.I have been diagnosed with chloroma.My low blood cell counts are not due to causes like stomach bleeding.More than 30% of my bone marrow is affected by scarring.I agree to use birth control during the study.I have a history of immune-related blood disorders.My heart function is weak or I have symptomatic heart disease.I have had a solid organ transplant.I haven't taken cyclosporine, antithymocyte globulin, or tacrolimus in the last 3 months.I have received a vaccine for myelodysplastic syndrome.I am HLA-A2 positive.I have received treatment for MDS in the last 4 weeks.I have been diagnosed with a specific type of MDS.I am fully active or can carry out light work.I haven't taken any MDS treatments like hormones or thalidomide in the last 4 weeks.I am not taking steroids, chemotherapy, or certain immune system drugs not allowed in the study.I have been diagnosed with MDS, either as a new case or due to previous treatment.My blood disorder is at an intermediate-1 stage or I need regular blood transfusions.I have been cancer-free for over 5 years, except for certain skin cancers or early-stage cervical or breast cancer.I have a history of Wegener's granulomatosis or vasculitis.My lung function is significantly reduced.I haven't taken high doses of steroids for more than 2 weeks in the last month.I have been diagnosed with HIV/AIDS.I have had a bone marrow transplant from a donor or twin.I have had acute myeloid leukemia in the past.
Research Study Groups:
This trial has the following groups: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.
Are enrollment opportunities still available for this experiment?
"Clinicaltrials.gov states that this medical study, which was initially advertised on January 1st 2007 and last updated March 1st 2014, is not currently recruiting patients. Nevertheless, there are 1593 other clinical trials actively seeking volunteers at the moment."
Answered by AI
What is the potential risk associated with this treatment for individuals?
"The safety rating for this medical intervention was appraised as a 2, given the lack of efficacy data from Phase 2 trials."
Answered by AI
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