Dendritic Cell Activating Scaffold in Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
F. Stephen Hodi, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01753089
First received: December 17, 2012
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Melanoma
Biological: WDVAX
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

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

  • Safety and Biologic Activity of WDVAX [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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:
  • Immune Response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Tumor Response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Response to subsequent immunotherapy (E.G., anit-CTLA-4 or anti_PD-1mAbs [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: June 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
WDVAX
Treatment
Biological: WDVAX

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753089

Contacts
Contact: F. Stephen Hodi, MD 6176325053 fhodi@partners.org

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: F. Stephen Hodi, MD    617-632-5053    fhodi@partners.org   
Contact: Caryn Kata, RN    617-582-7603    caryn_kata@dfci.harvard.edu   
Principal Investigator: F. Stephen Hodi, MD         
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: F. Stephen Hodi, MD    617-632-5053    fhodi@partners.org   
Principal Investigator: F. Stephen Hodi, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: F. Stephen Hodi, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: F. Stephen Hodi, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01753089     History of Changes
Other Study ID Numbers: 12-306
Study First Received: December 17, 2012
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Metastatic

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 19, 2014