← Back to Search

Cancer Vaccine

Vaccine Therapy for Melanoma

Phase 2

Waitlist Available

Led By David Avigan, 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

No mucosal or ocular melanoma

Performance status: ECOG 0-1

Must not have

Chemotherapy: No prior chemotherapy for metastatic melanoma

Radiotherapy: More than 6 weeks since prior radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying vaccines made from a patient's dendritic cells to see if they can help the body build an immune response to kill tumor cells.

Who is the study for?

This trial is for people with advanced skin cancer (stage III or IV melanoma). They must have a certain level of white blood cells and platelets, normal liver and kidney function, no other cancers in the last 5 years except some skin cancers or cervical carcinoma in situ. Participants can't be pregnant, must use contraception if fertile, and should not have any serious diseases that would interfere with the study.

What is being tested?

The trial is testing vaccine therapies made from patients' own immune cells mixed with either gp100 antigen or their tumor cells to see which combination better stimulates the body's defense against melanoma. It's a phase II study where patients are randomly assigned to one of these treatment groups.

What are the potential side effects?

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

Eligibility Criteria

Inclusion Criteria

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

Select...

My melanoma is not located in mucosal or ocular areas.

Select...

I am fully active or can carry out light work.

Select...

My bilirubin level is below 2.0 mg/dL.

Select...

I don't have an active infection, significant autoimmune or immune deficiency disorder, and I am HIV negative.

Select...

My skin cancer is confirmed as melanoma under a microscope.

Select...

My condition is in stage III or IV.

Select...

My cancer cells are gp100 positive and I have the HLA-A201 gene.

Select...

My tumor can be surgically removed and is larger than 2 cm.

Select...

My cancer has not spread to my brain.

Select...

My creatinine level is below 2.0 mg/dL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had chemotherapy for metastatic melanoma.

Select...

It has been over 6 weeks since my last radiotherapy session.

Select...

I am not currently taking any corticosteroids.

Select...

I am not on any drugs that weaken my immune system.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm IIExperimental Treatment2 Interventions

Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may receive an additional 6 courses.

Group II: Arm IExperimental Treatment1 Intervention

Patients undergo surgical harvesting of tumor cells for subsequent fusion. Patients receive vaccination comprising dendritic cells (DC) fused with autologous tumor cells subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who achieve a partial (PR) or complete response (CR) may receive an additional 3 courses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

autologous dendritic cell-tumor fusion vaccine

2010

Completed Early Phase 1

~20

GP-100 antigen

Not yet FDA approved

therapeutic autologous dendritic cells

2006