WDVAX Vaccine for Melanoma
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are receiving other investigational study agents or have an active autoimmune disease requiring treatment, you may not be eligible to participate.
What data supports the effectiveness of the WDVAX treatment for melanoma?
What safety data exists for the WDVAX Vaccine for Melanoma?
How is the WDVAX treatment for melanoma different from other treatments?
What is the purpose of this trial?
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of investigational melanoma vaccines. Phase I studies also try to define the appropriate dose of the investigational vaccine, in this case WDVAX, to use for further studies. "Investigational" means that the vaccine is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved WDVAX for any use in patients, including people with Melanoma.The purpose of this study is to determine if it is possible to make a vaccine against melanoma by using your own melanoma tumor cells and combining them with other proteins which activate the immune system. We hope that by combining the cells and the proteins in this way that the vaccine will cause your own immune system to react against your melanoma tumor cells. The purpose of this study is also to determine the safest way to give this vaccine with the least amount of side effects.Each vaccine will contain your own tumor cells which have been killed by a freezing and thawing process which destroys the cells but keeps the proteins from the melanoma cells. This is called a "tumor lysate" Your tumor lysate is combined with other proteins which activate the immune system. The other proteins are called GM-CSF and CpG. All of this is held together to form a "tablet" or "scaffold" which is about the size of a regular aspirin tablet. The material that holds the protein together is called PLGA. PLGA is the same material that doctors use for "dissolvable stitches" If you have ever had a problem with these types of stitches in the past, be sure to let your study doctor know about this.
Research Team
F. Stephen Hodi, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for adults with Stage IV melanoma who have lived at least six months after diagnosis, haven't had treatment in four weeks, and recovered from previous therapy side effects. They must not be pregnant or breastfeeding, have no allergies to PLG (used in dissolvable stitches), no active autoimmune diseases needing suppression, no uncontrolled illnesses, and should be free of other cancers for five years.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Vaccine Preparation
Surgical removal of tumor tissue for vaccine preparation and recovery
Treatment
Participants receive 4 vaccinations with WDVAX at varying intervals (every 2, 3, or 4 weeks)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with tumor assessments and side effect monitoring
Long-term Follow-up
Annual follow-up to monitor long-term effects and collect information on other therapies
Treatment Details
Interventions
- WDVAX
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor