← Back to Search

Cancer Vaccine

Vaccine Therapy +/− Interleukin-2 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

Renal: Creatinine less than 2.0 mg/dL, No clinically significant renal disease

Hepatic: Bilirubin less than 2.0 mg/dL, No clinically significant hepatic disease, Hepatitis B surface antigen negative

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 when given with or without interleukin-2 in treating patients with melanoma that cannot be removed by surgery.

Who is the study for?

This trial is for adults over 18 with advanced melanoma (stage III or IV) that can't be removed by surgery. Participants must have a good performance status, adequate blood cell counts, and normal liver and kidney function. They should not have significant heart disease, psychiatric disorders that affect compliance, autoimmune diseases, other major illnesses affecting the immune system, active infections needing IV antibiotics, or be pregnant. Effective contraception is required for fertile participants.Check my eligibility

What is being tested?

The study is testing whether vaccine therapy made from a patient's white blood cells mixed with melanoma antigens improves when combined with Interleukin-2. This Phase I/II trial aims to see if this combination helps the body fight off stage III or IV melanoma better than the vaccine alone.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site from the vaccine and flu-like symptoms such as fever and chills due to Interleukin-2. There may also be an increased risk of infection because of changes in how your immune system works.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidney function is normal, with creatinine below 2.0 mg/dL.

Select...

My liver functions are normal, and I don't have hepatitis B.

Select...

My brain and nervous system are stable, with no worsening conditions.

Select...

My melanoma is confirmed to be at an advanced stage.

Select...

I am fully active or can carry out light work.

Select...

I am 18 years old or older.

Select...

My condition cannot be treated with surgery and there are no other treatments available.

Select...

I do not have any serious heart conditions.

Select...

My cancer tests positive for gp100 and MART-1.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyLead Sponsor

524 Previous Clinical Trials

85,593 Total Patients Enrolled

Amy E. BockStudy ChairGenzyme, a Sanofi Company

1 Previous Clinical Trials

Media Library

Vaccine Therapy (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT00004025 — Phase 1 & 2

Skin Cancer Clinical Trial 2023: Vaccine Therapy Highlights & Side Effects. Trial Name: NCT00004025 — Phase 1 & 2

Vaccine Therapy (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00004025 — Phase 1 & 2

Frequently Asked Questions

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

Are participants being accepted at this time for the trial?

"The data posted on clinicaltrials.gov indicates that no new participants are being sought for this trial, which was initially published in March 1999 and most recently reviewed in January 2014. Nonetheless, there are 758 other trials actively recruiting patients at the moment."

Answered by AI