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

Melanoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257465
• Other study ID #: A/100/0401
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 22, 2005
• Last updated: December 2, 2015
• Start date: June 2005
• Est. completion date: June 2008

Study information

• Verified date: December 2015
• Source: AVAX Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• Autologous, DNP-modified vaccine (M-Vax)
5.0, 2.5, 0.5, or 0 cells
• Autologous, DNP-Modified Melanoma Vaccine
5 million cells
• Autologous, DNP-Modified Vaccine
2.5 million cells
• Autologous, DNP-Modified Vaccine
0.5 million cells
• Autologous, DNP-Modified Vaccine
0 cells

Locations

Country	Name	City	State
United States	University of Illinois School of Medicine	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Louisville	Louisville	Kentucky
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Pacific Oncology and Hematology Associates	San Diego	California
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AVAX Technologies

Country where clinical trial is conducted

United States, 

References & Publications (1)

Berd D, Sato T, Maguire HC Jr, Kairys J, Mastrangelo MJ. Immunopharmacologic analysis of an autologous, hapten-modified human melanoma vaccine. J Clin Oncol. 2004 Feb 1;22(3):403-15. Epub 2003 Dec 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune response to patients' own melanoma cells		2 months	No
Secondary	Safety		9 months	Yes