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

AVAX Technologies

Status and phase: Completed; Phase 2; Phase 1

Conditions: Melanoma

Treatments: Biological: Autologous, DNP-Modified Vaccine; Biological: Autologous, DNP-Modified Melanoma Vaccine; Biological: Autologous, DNP-modified vaccine (M-Vax)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00257465

A/100/0401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 4 patient groups, including a placebo group

A

Experimental group

Description:

'Autologous, DNP-modified vaccine (M-Vax)'

Treatment:

Biological: Autologous, DNP-modified vaccine (M-Vax)

Biological: Autologous, DNP-Modified Melanoma Vaccine

B

Experimental group

Description:

Autologous, DNP-Modified Vaccine (MVax)

Treatment:

Biological: Autologous, DNP-Modified Vaccine

Biological: Autologous, DNP-Modified Vaccine

Biological: Autologous, DNP-modified vaccine (M-Vax)

Biological: Autologous, DNP-Modified Vaccine

C

Experimental group

Description:

Autologous, DNP-Modified Vaccine (MVax)

Treatment:

Biological: Autologous, DNP-Modified Vaccine

Biological: Autologous, DNP-Modified Vaccine

Biological: Autologous, DNP-modified vaccine (M-Vax)

Biological: Autologous, DNP-Modified Vaccine

D

Placebo Comparator group

Description:

0 cells

Treatment:

Biological: Autologous, DNP-Modified Vaccine

Biological: Autologous, DNP-Modified Vaccine

Biological: Autologous, DNP-Modified Vaccine