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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Melanoma

Intervention / Treatment
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* Biological: Autologous, DNP-modified vaccine (M-Vax)
* Biological: Autologous, DNP-Modified Melanoma Vaccine
* Biological: Autologous, DNP-Modified Vaccine
* Biological: Autologous, DNP-Modified Vaccine
* Biological: Autologous, DNP-Modified Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>'Autologous, DNP-modified vaccine (M-Vax)' | Biological: Autologous, DNP-modified vaccine (M-Vax)<br>* 5.0, 2.5, 0.5, or 0 cells<br>Biological: Autologous, DNP-Modified Melanoma Vaccine<br>* 5 million cells<br>* Other names: MVax;|
| Experimental: B<br>Autologous, DNP-Modified Vaccine (MVax) | Biological: Autologous, DNP-modified vaccine (M-Vax)<br>* 5.0, 2.5, 0.5, or 0 cells<br>Biological: Autologous, DNP-Modified Vaccine<br>* 2.5 million cells<br>* Other names: MVax;|
| Experimental: C<br>Autologous, DNP-Modified Vaccine (MVax) | Biological: Autologous, DNP-modified vaccine (M-Vax)<br>* 5.0, 2.5, 0.5, or 0 cells<br>Biological: Autologous, DNP-Modified Vaccine<br>* 0.5 million cells<br>* Other names: MVax;|
| Placebo Comparator: D<br>0 cells | Biological: Autologous, DNP-Modified Vaccine<br>* 0 cells<br>* Other names: MVax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune response to patients' own melanoma cells |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melanoma, metastatic, vaccine, immunotherapy, autologous