WDVAX Vaccine for Melanoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byF. Stephen Hodi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

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.

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

It has been over 8 weeks since my last immunotherapy treatment.

My melanoma is confirmed to be at stage IV.

I have recovered from side effects of my previous treatments.

+2 more

Exclusion Criteria

I have been cancer-free for 5 years, or I had treated skin cancer or cervical cancer in situ.

I am currently being treated for an autoimmune disease.

I do not have any uncontrolled illnesses.

+4 more

Participant Groups

The study tests WDVAX—a vaccine made from a patient's own tumor cells mixed with immune-activating proteins GM-CSF and CpG within a 'scaffold' similar to dissolvable stitches material. It aims to find the safest dose with minimal side effects that can trigger an immune response against melanoma.

1Treatment groups

Experimental Treatment

Group I: WDVAXExperimental Treatment1 Intervention

Treatment