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Phase II, Open-Label Trial in Patients With Stage IV Malignant Melanoma Using Melaxin as a Cancer Vaccine in Conjunction With BCG

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II, Open-Label Trial in Patients With Stage IV Malignant Melanoma Using Melaxin as a Cancer Vaccine in Conjunction With BCG

Chemotherapy and immunotherapy are the main therapies for metastatic melanoma with the hope
of prolonging survival. The ideal immunotherapy would consist of the professional
antigen-presenting cell, the dendritic cell, with the entire repertoire of tumor antigens
inside. The best way to achieve this is by creating an autologous hybrid fusion cell of the
dendritic cell and tumor cell. In this study, melanoma tumor tissue surgically removed from
the patient will be disassociated into single cells, irradiated and fused to dendritic cells
produced by culturing the patient's blood monocytes. Prior to the electrofusion procedure,
the tumor cells are stained red and the dendritic cells are stained green. After fusion,
the uniquely colored fused cells, or dendritomas, are separated from the unfused cells by
use of a fluorescence activated cell sorter. This highly purified population is then
divided into 4 doses containing 250,000 dendritomas each and frozen. Each dose is thawed,
diluted to 1 ml with Sterile Saline for Injection containing 5% human serum albumin and
administered subcutaneously over a lymph node bed to the patient once every 4 weeks. A
separate injection of BCG is administered in the same area within 10 minutes of the
dendritoma injection. The safety and efficacy of the therapy will be evaluated in 25

Inclusion Criteria:

- Ability to give informed consent

- Male or female patient whose age is > 18 years of age

- Histological documented Stage IV malignant melanoma (AJCC sixth edition)

- Pathology report from tumor specimen verifying melanoma diagnosis

- Free of infection

- Hemoglobin> 9.0gm/dL, WBC>3000/mm3, platelets> 100,000mm3

- Liver function test that are less than 2 times the upper limit of normal of the
reference range for the testing laboratory

- Adequate cardiac function-any evidence of ischemic heart disease demonstrated by
history, physical, or EKG will require referral to a cardiologist for evaluation and
clearance prior to protocol therapy

- No immunotherapy within the past 3 months

- A minimum of 4 doses of lot-released, autologus Melaxin (1.0 million dendritomas)

Exclusion Criteria:

- Other malignancies in the past 5 years with the exception of non-melanoma skin cancer
or carcinoma in situ of the cervix

- Has received any immunosuppressive agent within 30 days prior to treat

- Creatinine> 2.5mg/dL or currently on dialysis

- Positive serum pregnancy test, breast-feeding,or planning to conceive or father or
father a child in the period surrounding the study as described in the informed

- Women of childbearing potential who cannot follow the directions for birth control

- ECOG performance status greater than 3

- Positive Rdonr panel (HIV 1, 2; HTLV 1,2; Hepatitis B and C)

- History of a seizure disorder

- Brain metastases that have progressed within the last 6 months

- No measurable disease

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events and clinical laboratory results

Outcome Time Frame:

From first vaccine to 6 weeks after the last

Safety Issue:


Principal Investigator

Thomas E Wagner, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Greenville Hospital System


United States: Food and Drug Administration

Study ID:

CC/ORI 07-02



Start Date:

April 2008

Completion Date:

March 2009

Related Keywords:

  • Melanoma
  • Melanoma
  • Dendritic cells
  • Cell therapy
  • BCG vaccine
  • Melanoma



Cancer Center of Carolinas/Clinical Research Unit 3rd FloorGreenville, South Carolina  29605