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

Phase 1

Completed

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

• Registration Number: NCT00257465
• Lead Sponsor: AVAX Technologies

Brief Summary

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

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-11-22
• Study First Submitted QC: 2005-11-22
• Study First Posted: 2005-11-23
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Autologous, DNP-Modified Vaccine	Autologous, DNP-Modified Vaccine (MVax)
A	Autologous, DNP-modified vaccine (M-Vax)	'Autologous, DNP-modified vaccine (M-Vax)'
A	Autologous, DNP-Modified Melanoma Vaccine	'Autologous, DNP-modified vaccine (M-Vax)'
C	Autologous, DNP-Modified Vaccine	Autologous, DNP-Modified Vaccine (MVax)
C	Autologous, DNP-modified vaccine (M-Vax)	Autologous, DNP-Modified Vaccine (MVax)
B	Autologous, DNP-modified vaccine (M-Vax)	Autologous, DNP-Modified Vaccine (MVax)
D	Autologous, DNP-Modified Vaccine	0 cells

Primary Outcome Measures

Name	Time	Method
Immune response to patients' own melanoma cells	2 months

Secondary Outcome Measures

Name	Time	Method
Safety	9 months

Trial Locations

Locations (7)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Pacific Oncology and Hematology Associates; 🇺🇸 San Diego, California, United States

University of Illinois School of Medicine; 🇺🇸 Chicago, Illinois, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States