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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.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 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 belowSelect...
My melanoma is not located in mucosal or ocular areas.
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I am fully active or can carry out light work.
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My bilirubin level is below 2.0 mg/dL.
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I don't have an active infection, significant autoimmune or immune deficiency disorder, and I am HIV negative.
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My skin cancer is confirmed as melanoma under a microscope.
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My condition is in stage III or IV.
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My cancer cells are gp100 positive and I have the HLA-A201 gene.
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My tumor can be surgically removed and is larger than 2 cm.
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My cancer has not spread to my brain.
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My creatinine level is below 2.0 mg/dL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immune response
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
Completed Phase 2
~550
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,832 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,113 Total Patients Enrolled
David Avigan, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
14 Previous Clinical Trials
419 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had melanoma vaccine therapy or immunotherapy in the last 6 weeks.I have not had chemotherapy for metastatic melanoma.My melanoma is not located in mucosal or ocular areas.My age does not limit my participation.I am fully active or can carry out light work.My bilirubin level is below 2.0 mg/dL.It has been over 6 weeks since my last radiotherapy session.I don't have an active infection, significant autoimmune or immune deficiency disorder, and I am HIV negative.I am not currently taking any corticosteroids.My surgery status is not relevant for this trial.My condition is in stage III or IV.My creatinine level is below 2.0 mg/dL.My cancer cells are gp100 positive and I have the HLA-A201 gene.My tumor can be surgically removed and is larger than 2 cm.My cancer has not spread to my brain.I am not on any drugs that weaken my immune system.My skin cancer is confirmed as melanoma under a microscope.My stage III cancer cannot be surgically removed and there's no definitive treatment for it.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I
- Group 2: Arm II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you elaborate on any previous experiments with autologous dendritic cell-tumor fusion vaccine?
"Currently, only one clinical trial for autologous dendritic cell-tumor fusion vaccine is active, not yet having reached Phase 3. This study can be located in Boston and two other cities around the USA."
Answered by AI
How precarious is the risk associated with autologous dendritic cell-tumor fusion vaccine treatments?
"Our team at Power's safety rating for autologous dendritic cell-tumor fusion vaccine is 2 due to the Phase 2 clinical trial status, with existing data indicating that the treatment is reasonably safe but without any evidence of efficacy."
Answered by AI
What is the size of the cohort involved in this experiment?
"This particular clinical trial is closed for recruitment. Initially posted on March 1st, 2004 and most recently updated February 6th, 2009; it currently does not accept new participants. Nevertheless, 758 trials are open to those with malignant melanoma of skin while a single autologous dendritic cell-tumor fusion vaccine study remains available as well."
Answered by AI
Is enrollment for this scientific experiment still open?
"This medical trial is not presently accepting patients. The initial clinicaltrials.gov posting date was March 1st, 2004 with the most recent edit occurring on February 6th 2009. Fortunately, there are currently 759 other trials actively searching for volunteers in various locations around the world."
Answered by AI
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