Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

Dendritic Cell Activating Scaffold in Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01753089
Recruitment Status : Active, not recruiting
First Posted : December 20, 2012
Last Update Posted : January 19, 2023
Information provided by (Responsible Party):
F. Stephen Hodi, MD, Dana-Farber Cancer Institute

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Melanoma Biological: WDVAX Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of a Dendritic Cell Activating Scaffold Incorporating Autologous Melanoma Cell Lysate (WDVAX) in Metastatic Melanoma Patients
Actual Study Start Date : June 2013
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Biological: WDVAX

Primary Outcome Measures :
  1. Feasibility of WDVAX for Metastatic Melanoma [ Time Frame: 2 years ]
    To determine the feasibility of preparing dendritic cells activating scaffolds (WDVAX) incorporating autologous melanoma cell lysates in patients with metastatic melanoma

  2. Safety and Biologic Activity of WDVAX [ Time Frame: 2 years ]
    To determine the safety and biologic activity of vaccination with dendritic cell activation scaffolds (WDVAX) incorporating autologous melanoma cell lysates in patients with metastatic melanoma

Secondary Outcome Measures :
  1. Immune Response [ Time Frame: 2 years ]
  2. Tumor Response [ Time Frame: 2 years ]
  3. Survival [ Time Frame: 2 years ]
  4. Response to subsequent immunotherapy (E.G., anit-CTLA-4 or anti_PD-1mAbs [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed Stage IV melanoma
  • Life expectancy of 6 months or greater
  • At least four weeks since treatment
  • Recovered from any acute toxicity associated with prior therapy
  • At least 8 weeks since treatment with any check point blockade agent

Exclusion Criteria:

  • Known allergy or adverse reaction to PLG
  • Pregnant or breastfeeding
  • Receiving other investigational study agents
  • Active autoimmune disease requiring treatment for suppression of inflammation
  • Uncontrolled intercurrent illness
  • History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, basal or squamous cell carcinoma of the skin
  • HIV positive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01753089

Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Layout table for investigator information
Principal Investigator: F. Stephen Hodi, MD Dana-Farber Cancer Institute
Layout table for additonal information
Responsible Party: F. Stephen Hodi, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT01753089    
Other Study ID Numbers: 12-306
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
Keywords provided by F. Stephen Hodi, MD, Dana-Farber Cancer Institute:
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas