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Cancer Vaccine

Melanoma Vaccine for Skin Cancer

Phase 1

Waitlist Available

Led By F. Stephen Hodi, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stage III patients must have lymphadenopathy of at least 2cm in greatest diameter by physical exam or CT scan in a region draining a known or suspected primary melanoma or in transit metastatic disease of at least 2cm in greatest diameter by physical exam or CT in a region draining a known primary melanoma

Stage III patients must be able to have all measurable disease removed at time of tumor harvest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

Study Summary

This trial is testing a new cancer therapy to see if it can delay or stop the progression of skin cancer. There are currently no effective treatments for this disease, so this study is important in evaluating a new potential treatment.

Who is the study for?

This trial is for adults over 18 with Stage III melanoma who've had all measurable disease removed and have not received recent cancer treatments. It's also open to those with Stage IV metastatic melanoma, provided they haven't been treated with certain therapies or had a stem cell transplant within the last six months.Check my eligibility

What is being tested?

The study tests vaccines made from patients' own skin cancer cells that have been modified to secrete GMSF, an immune system stimulator. The goal is to see if this vaccine can halt or slow down the progression of melanoma in participants.See study design

What are the potential side effects?

While specific side effects are not listed, clinical side effects related to the immune response generated by the vaccine will be monitored. This could potentially include flu-like symptoms, injection site reactions, and other immune-related events.

Eligibility Criteria

Inclusion Criteria

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

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I have stage III melanoma with lymph nodes or in-transit disease larger than 2cm.

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All my Stage III cancer can be surgically removed.

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My melanoma is stage IV and has been confirmed through tissue examination.

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My stage III melanoma is confirmed by tissue analysis.

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I have stage III cancer and cannot or have not responded to high dose a-interferon treatment.

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I am fully active or can carry out light work.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine the doses of lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete CM-CSF that can be manufactured in stage III melanoma patients.

Secondary outcome measures

To determine more fully the safety and biologic activity of vaccination with lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete GM-CSF in stage IV melanoma patients

Vaccination

To determine the two-year survival of stage IV melanoma patients vaccinated with lethally irradiated, autologous melanoma cells engineered by adenoviral mediated gene transfer to secrete GM-CSF