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Completed

NCT Number: NCT00257465

Trial of Autologous, Hapten-Modified Vaccine 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.

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Key information

Conditions

Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Arizona Cancer Center, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous, DNP-modified vaccine (M-Vax)

Biological

5.0, 2.5, 0.5, or 0 cells

Autologous, DNP-Modified Melanoma Vaccine

Biological

5 million cells

Other names: MVax

Autologous, DNP-Modified Vaccine

Biological

2.5 million cells

Other names: MVax

Primary outcomes

  1. Immune response to patients' own melanoma cells

    Time frame: 2 months

Secondary outcomes

  1. Safety

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

AVAX Technologies

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 23, 2005
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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