Trial of Autologous, Hapten-Modified Vaccine in Patients With Stage III or IV Melanoma - Full Text View

Sponsored by:	AVAX Technologies
Information provided by:	AVAX Technologies
ClinicalTrials.gov Identifier:	NCT00257465

Purpose

The purpose of this study is to determine whether a vaccine composed of patients' own melanoma cells treated with the chemical, dinitrophenyl (DNP)(called a hapten), is safe and stimulates an immune response to patients' own cancer cells.

Condition	Intervention	Phase
Melanoma	Biological: Autologous, DNP-modified vaccine (M-Vax) Biological: Autologous, DNP-Modified Melanoma Vaccine Biological: Autologous, DNP-Modified Vaccine	Phase I Phase II

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	M-Vax: A Feasibility and Bio-Equivalence Study Using a DNP-Modified Autologous Melanoma Tumor Cell Vaccine as Therapy in Patients With Stage III or IV Melanoma

Further study details as provided by AVAX Technologies:

Primary Outcome Measures:

Immune response to patients' own melanoma cells [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	56
Study Start Date:	June 2005
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 'Autologous, DNP-modified vaccine (M-Vax)'	Biological: Autologous, DNP-modified vaccine (M-Vax) 5.0, 2.5, 0.5, or 0 cells Biological: Autologous, DNP-Modified Melanoma Vaccine 5 million cells
B: Experimental Autologous, DNP-Modified Vaccine (MVax)	Biological: Autologous, DNP-modified vaccine (M-Vax) 5.0, 2.5, 0.5, or 0 cells Biological: Autologous, DNP-Modified Vaccine 2.5 million cells
C: Experimental Autologous, DNP-Modified Vaccine (MVax)	Biological: Autologous, DNP-modified vaccine (M-Vax) 5.0, 2.5, 0.5, or 0 cells Biological: Autologous, DNP-Modified Vaccine 0.5 million cells
D: Placebo Comparator 0 cells	Biological: Autologous, DNP-Modified Vaccine 0 cells

Detailed Description:

Patients with stage III or IV melanoma need to have at least one tumor mass of at least 2.5 cm (about 1 inch) diameter than can be removed for vaccine production. If the vaccine is successfully made and if the patient is eligible, the patient will be assigned to receive one of 4 doses of the vaccine, include one group that will receive a zero dose. All patients will receive injections of their vaccine as part of immune system testing and will receive low dose cyclophosphamide and BCG. Eight injections of the vaccine will be administered as an injection into the skin of the arm over a 6 month period. Before and after vaccine administration, patients will be tested for immunity to their own melanoma cells by DTH testing, which is similar to a tuberculosis test. All side effects caused by the vaccine will be recorded.

Eligibility

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

Criteria

Inclusion Criteria:

stage III or IV melanoma at least one tumor mass of at least 2.5 cm diameter that can be excised to make vaccine good performance status

Exclusion Criteria:

brain metastases need for steroids or other immunosuppressive drugs positive PPD tests positive test for HIV, hepatitis B (antigen), or hepatitis C other serious medical illnesses

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257465

Locations

United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States
United States, California
Pacific Oncology and Hematology Associates
San Diego, California, United States, 92024
United States, Illinois
University of Illinois School of Medicine
Chicago, Illinois, United States, 60612
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

AVAX Technologies

Investigators

Principal Investigator:

David Berd, MD

AVAX Technologies

More Information

Publications:

Berd D, Sato T, Maguire HC Jr, Kairys J, Mastrangelo MJ. Immunopharmacologic analysis of an autologous, hapten-modified human melanoma vaccine. J Clin Oncol. 2004 Feb 1;22(3):403-15. Epub 2003 Dec 22.

Responsible Party:	AVAX Technologies ( David Berd, Chief Medical Officer )
Study ID Numbers:	A/100/0401
Study First Received:	November 22, 2005
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00257465
Health Authority:	United States: Food and Drug Administration

Keywords provided by AVAX Technologies:

melanoma
metastatic
vaccine
immunotherapy
autologous

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 13, 2009