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Cancer Vaccine

Vaccine Therapy +/− Sargramostim for Melanoma

Phase 1

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 Karnofsky 80-100%

Hematopoietic: Neutrophil count at least 1,500/mm3, Lymphocyte count at least 500/mm3, Platelet count at least 100,000/mm3, Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg), No bleeding disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well giving a vaccine therapy together with sargramostim works in treating patients with metastatic melanoma.

Who is the study for?

This trial is for adults with high-risk or metastatic melanoma who have tried, declined, or finished standard treatments. They must not have active brain metastases and should be HLA-A2 positive. Participants need to be in good physical condition (Karnofsky score of 80-100%), with adequate organ function and blood counts, no serious illnesses including heart disease, infections requiring antibiotics, immunodeficiency diseases, autoimmune diseases or psychiatric/addictive disorders that could interfere with the study. Pregnant or nursing women are excluded.Check my eligibility

What is being tested?

The trial is testing whether a vaccine therapy can stimulate the immune system to fight melanoma cells more effectively when combined with sargramostim—a substance that boosts white blood cell production—compared to the vaccine alone. Patients will be randomly assigned to receive either just the vaccine therapy or both the vaccine and sargramostim.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site like pain and redness, flu-like symptoms such as fever and chills, fatigue, muscle aches, and an increased risk of infection due to stimulation of the immune system.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly self-sufficient and active.

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My blood counts meet the required levels and I don't have a bleeding disorder.

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My creatinine level is 1.8 mg/dL or lower.

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My heart condition does not severely limit my daily activities.

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My melanoma is confirmed to be at a high-risk stage III or IV.

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I have either declined, failed, or completed standard treatment.

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I do not have a serious infection needing antibiotics.

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I do not have any immune system or autoimmune diseases.

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My bilirubin levels are 2.0 mg/dL or lower and I don't have hepatitis B or C.

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I am HLA-A2 positive.

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My brain metastases are treated and stable.

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I am 18 years old or older.

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 / 12Eligibility criteria met

Find a Location

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

Kyriakos P. Papadopoulos, MDStudy ChairHerbert Irving Comprehensive Cancer Center

1 Previous Clinical Trials

Media Library

Skin Cancer Clinical Trial 2023: Vaccine Therapy Highlights & Side Effects. Trial Name: NCT00037037 — Phase 1

Frequently Asked Questions

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

Are people still able to join the clinical trial at this time?

"According to the clinicaltrials.gov website, this particular medical trial is not currently recruiting participants. Originally posted on October 1st 2001 and last updated December 17th 2013, there are 757 other studies actively enrolling patients as of now."

Answered by AI

What assurances can be given to patients regarding the protection of their well-being through this therapeutic approach?

"Our team at Power assessed the safety of this treatment as a 1 due to it being in Phase 1 trials, meaning there is only sparse information regarding efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma

2001. "Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00037037.