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Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma

This study is currently recruiting participants.
Verified by Greenville Hospital System University Medical Center, April 2008

Sponsors and Collaborators: Greenville Hospital System University Medical Center
Oncolix
Information provided by: Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier: NCT00671554
  Purpose

The purpose of this study is to determine if treatment with the autologous cellular vaccine, Melaxin, in combination with Bacillus Calmette-Guerin (BCG) injections is effective in Stage IV malignant melanoma.


Condition Intervention Phase
Melanoma
Biological: Melaxin (autologous dendritoma vaccine) and BCG
Phase I
Phase II

MedlinePlus related topics:   Cancer    Melanoma   

ChemIDplus related topics:   BCG Vaccine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Single Group Assignment
Official Title:   Phase II, Open-Label Trial in Patients With Stage IV Malignant Melanoma Using Melaxin as a Cancer Vaccine in Conjunction With BCG

Further study details as provided by Greenville Hospital System University Medical Center:

Primary Outcome Measures:
  • Adverse events and clinical laboratory results [ Time Frame: From first vaccine to 6 weeks after the last ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response as measured using the RECIST criteria [ Time Frame: 18 months after last vaccine ] [ Designated as safety issue: No ]

Estimated Enrollment:   25
Study Start Date:   April 2008
Estimated Study Completion Date:   April 2011
Estimated Primary Completion Date:   October 2009 (Final data collection date for primary outcome measure)

Intervention Details:
    Biological: Melaxin (autologous dendritoma vaccine) and BCG
    Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million CFU of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration.
Detailed Description:

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 patients.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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 consent.
  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671554

Contacts
Contact: Joe Stephenson, MD     864-679-3966    

Locations
United States, South Carolina
Cancer Center of Carolinas/Clinical Research Unit 3rd Floor     Recruiting
      Greenville, South Carolina, United States, 29605

Sponsors and Collaborators
Greenville Hospital System University Medical Center
Oncolix

Investigators
Study Director:     Thomas E Wagner, PhD     Greenville Hospital System    
  More Information


Responsible Party:   Greenville Hospital System ( Thomas E. Wagner, PhD/Director )
Study ID Numbers:   CC/ORI 07-02
First Received:   April 30, 2008
Last Updated:   May 2, 2008
ClinicalTrials.gov Identifier:   NCT00671554
Health Authority:   United States: Food and Drug Administration

Keywords provided by Greenville Hospital System University Medical Center:
Melanoma  
Dendritic cells  
Cell therapy  
BCG vaccine  

Study placed in the following topic categories:
BCG Vaccine
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 10, 2008




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