Clinical trial NCT00257465: Trial of Autologous, Hapten-Modified Vaccine in Patients With Stage III or IV Melanoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Melanoma
Keywords: melanoma
metastatic
vaccine
immunotherapy
autologous
Lead sponsor: AVAX Technologies
Sponsor class: INDUSTRY
First posted: 2005-11-23
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Immune response to patients' own melanoma cells
timeFrame: 2 months
Secondary outcomes:
measure: Safety
timeFrame: 9 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: San Diego
country: United States
facility: Pacific Oncology and Hematology Associates
state: California
city: Chicago
country: United States
facility: University of Illinois School of Medicine
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: AVAX Technologies
name: David Berd, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1200/JCO.2004.06.043. Epub 2003 Dec 22.