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

Intervention / Treatment

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

  • United States
    • 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
      • Louisville, Kentucky, United States
        • University of Louisville
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Texas
      • 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

16 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)'
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
Other Names:
  • MVax
Experimental: B
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
Other Names:
  • MVax
Biological: Autologous, DNP-Modified Vaccine
0.5 million cells
Other Names:
  • MVax
Biological: Autologous, DNP-Modified Vaccine
0 cells
Other Names:
  • MVax
Experimental: C
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
Other Names:
  • MVax
Biological: Autologous, DNP-Modified Vaccine
0.5 million cells
Other Names:
  • MVax
Biological: Autologous, DNP-Modified Vaccine
0 cells
Other Names:
  • MVax
Placebo Comparator: D
0 cells
Biological: Autologous, DNP-Modified Vaccine
2.5 million cells
Other Names:
  • MVax
Biological: Autologous, DNP-Modified Vaccine
0.5 million cells
Other Names:
  • MVax
Biological: Autologous, DNP-Modified Vaccine
0 cells
Other Names:
  • MVax

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

AVAX Technologies

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.

General Publications

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.

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