Trial of Autologous, Hapten-Modified Vaccine in Patients With Stage III or IV Melanoma
December 2, 2015 updated by: AVAX Technologies
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
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States
- University of Arizona Cancer Center
-
-
California
-
San Diego, California, United States, 92024
- Pacific Oncology and Hematology Associates
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- University of Illinois School of Medicine
-
-
Kentucky
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Louisville, Kentucky, United States
- University of Louisville
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
-
-
Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
'Autologous, DNP-modified vaccine (M-Vax)'
|
5.0, 2.5, 0.5, or 0 cells
5 million cells
Other Names:
|
|
Experimental: B
Autologous, DNP-Modified Vaccine (MVax)
|
5.0, 2.5, 0.5, or 0 cells
2.5 million cells
Other Names:
0.5 million cells
Other Names:
0 cells
Other Names:
|
|
Experimental: C
Autologous, DNP-Modified Vaccine (MVax)
|
5.0, 2.5, 0.5, or 0 cells
2.5 million cells
Other Names:
0.5 million cells
Other Names:
0 cells
Other Names:
|
|
Placebo Comparator: D
0 cells
|
2.5 million cells
Other Names:
0.5 million cells
Other Names:
0 cells
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Immune response to patients' own melanoma cells
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Berd, MD, AVAX Technologies
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
November 22, 2005
First Submitted That Met QC Criteria
November 22, 2005
First Posted (Estimate)
November 23, 2005
Study Record Updates
Last Update Posted (Estimate)
December 3, 2015
Last Update Submitted That Met QC Criteria
December 2, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A/100/0401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.