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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Immune response to patients' own melanoma cells

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

David Berd, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

AVAX Technologies

Authority:

United States: Food and Drug Administration

Study ID:

A/100/0401

NCT ID:

NCT00257465

Start Date:

June 2005

Completion Date:

June 2008

Related Keywords:

  • Melanoma
  • melanoma
  • metastatic
  • vaccine
  • immunotherapy
  • autologous
  • Melanoma

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
University of LouisvilleLouisville, Kentucky  40202
University of Arizona Cancer CenterTucson, Arizona  85724
Pacific Oncology and Hematology AssociatesSan Diego, California  92024
University of Illinois School of MedicineChicago, Illinois  60612