Trial of Autologous, Hapten-Modified Vaccine in Patients With Stage III or IV Melanoma
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
1 other identifier
interventional
82
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2005
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 22, 2005
CompletedFirst Posted
Study publicly available on registry
November 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedDecember 3, 2015
December 1, 2015
3 years
November 22, 2005
December 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immune response to patients' own melanoma cells
2 months
Secondary Outcomes (1)
Safety
9 months
Study Arms (4)
A
EXPERIMENTAL'Autologous, DNP-modified vaccine (M-Vax)'
B
EXPERIMENTALAutologous, DNP-Modified Vaccine (MVax)
C
EXPERIMENTALAutologous, DNP-Modified Vaccine (MVax)
D
PLACEBO COMPARATOR0 cells
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Arizona Cancer Center
Tucson, Arizona, United States
Pacific Oncology and Hematology Associates
San Diego, California, 92024, United States
University of Illinois School of Medicine
Chicago, Illinois, 60612, United States
University of Louisville
Louisville, Kentucky, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
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. doi: 10.1200/JCO.2004.06.043. Epub 2003 Dec 22.
PMID: 14691123BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Berd, MD
AVAX Technologies
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2005
First Posted
November 23, 2005
Study Start
June 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
December 3, 2015
Record last verified: 2015-12