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Cancer Vaccine

Vaccine Therapy for Melanoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Genzyme, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: 18 or over
Renal: Creatinine less than 2 mg/dL, No clinically significant renal disease that would preclude study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying how well vaccine therapy works in treating patients with melanoma that has spread to nearby tissues or lymph nodes.

Who is the study for?
This trial is for adults over 18 with stage II, III, or IV melanoma who've had surgery in the last year. They must be healthy overall with good heart, liver, and kidney function and no serious diseases like HIV or hepatitis. Pregnant women can't join, and participants must use birth control.Check my eligibility
What is being tested?
The study is testing a vaccine therapy to see if it helps the immune system destroy melanoma cells. It's for patients without current signs of cancer after surgery. The trial will check how safe the vaccine is (Phase I) and how well it works (Phase II).See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, flu-like symptoms such as fever or chills, fatigue, headache, muscle pain, possible autoimmune responses due to immune system activation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My kidney function is normal, with creatinine less than 2 mg/dL.
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My current tests show no signs of cancer.
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I am HLA-A2 positive.
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My blood cell counts meet the required levels and I don't have significant blood diseases.
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I am fully active or can carry out light work.
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My skin cancer is confirmed as stage II, III, or IV melanoma.
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My heart health does not prevent me from joining the study.
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I had surgery to completely remove my cancer within the last year.
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My liver function tests are within normal limits and I don't have significant liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyLead Sponsor
524 Previous Clinical Trials
85,629 Total Patients Enrolled
Amy E. BockStudy ChairGenzyme, a Sanofi Company
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Vaccine Therapy (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT00010309 — Phase 1 & 2
Skin Cancer Research Study Groups:
Skin Cancer Clinical Trial 2023: Vaccine Therapy Highlights & Side Effects. Trial Name: NCT00010309 — Phase 1 & 2
Vaccine Therapy (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00010309 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research experiment still open to potential participants?

"The information found on clinicaltrials.gov indicates that this medical research is no longer actively enrolling patients; it was first published in November 1st 2000 and last edited on January 3rd 2014. Nevertheless, 758 other trials remain open to participants."

Answered by AI
~14 spots leftby Apr 2025