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

This study has been terminated.
(Due to business considerations; not due to toxicities or adverse events.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00671554
First Posted: May 5, 2008
Last Update Posted: June 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oncolix, Inc.
Information provided by (Responsible Party):
Greenville Health System
  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 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Open-Label Trial in Patients With Stage IV Malignant Melanoma Using Melaxin as a Cancer Vaccine in Conjunction With BCG

Resource links provided by NLM:


Further study details as provided by Greenville Health System:

Primary Outcome Measures:
  • Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results. [ Time Frame: From first vaccine to 18 months after the last injection ]
    Expected adverse events included injection site reactions, fever, chills, and arthralgias as anticipated with vaccine therapy. No unexpected or uncommon adverse events occurred such as disseminated sepsis. Clinical laboratory results on all participants were within expected ranges, including an increase in the number of IFN gamma expressing T-cells.


Secondary Outcome Measures:
  • Tumor Response Measured by RECIST Criteria and Progression-free Survival. [ Time Frame: From first vaccine to 18 months after the last injection ]
    CT scans for disease assessment occurred at three month intervals. If partial or complete responses were observed confirmation scans were performed within four weeks. Patients were followed for 18 months post study completion. All three participants recieved at least one vaccine, and all participants had progression of disease prior to the 18 month followup visit.


Enrollment: 3
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melaxin and BCG
Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration
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.
Other Name: Melaxin

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 milliliter (ml) with Sterile Saline for Injection containing 5 percent (%) human serum albumin and administered subcutaneously (SQ) over a lymph node bed to the patient once every 4 weeks. A separate injection of Bacillus Calmette-Guerin (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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 (American Joint Committee on Cancer (AJCC) sixth edition)
  • Pathology report from tumor specimen verifying melanoma diagnosis
  • Free of infection
  • Hemoglobin> 9.0 grams per deciliter (gm/dL), White Blood Cells (WBC) >3000/ cubic millimeters (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> 2.5 milligrams per deciliter (mg/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
  • Eastern Cooperative Oncology Group (ECOG) performance status greater than 3
  • Positive Rdonr panel (Human Immunodeficiency virus (HIV) 1, 2; Human T-lymphotropic virus (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671554


Locations
United States, South Carolina
Cancer Center of Carolinas/Clinical Research Unit 3rd Floor
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Greenville Health System
Oncolix, Inc.
Investigators
Study Director: Thomas E Wagner, PhD Greenville Hospital System
  More Information

Responsible Party: Greenville Health System
ClinicalTrials.gov Identifier: NCT00671554     History of Changes
Other Study ID Numbers: CC/ORI 07-02
First Submitted: April 30, 2008
First Posted: May 5, 2008
Results First Submitted: April 3, 2012
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014
Last Verified: May 2014

Keywords provided by Greenville Health System:
Melanoma
Dendritic cells
Cell therapy
BCG vaccine

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Vaccines
Immunologic Factors
Physiological Effects of Drugs