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

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ClinicalTrials.gov Identifier: NCT00671554
Recruitment Status : Terminated (Due to business considerations; not due to toxicities or adverse events.)
First Posted : May 5, 2008
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
Oncolix, Inc.
Information provided by (Responsible Party):
Prisma Health-Upstate

Tracking Information
First Submitted Date  ICMJE April 30, 2008
First Posted Date  ICMJE May 5, 2008
Results First Submitted Date  ICMJE April 3, 2012
Results First Posted Date  ICMJE June 4, 2014
Last Update Posted Date June 4, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2008)
Adverse events and clinical laboratory results [ Time Frame: From first vaccine to 6 weeks after the last ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2014)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2008)
Tumor response as measured using the RECIST criteria [ Time Frame: 18 months after last vaccine ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma
Official Title  ICMJE Phase II, Open-Label Trial in Patients With Stage IV Malignant Melanoma Using Melaxin as a Cancer Vaccine in Conjunction With BCG
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Biological: Melaxin (autologous dendritoma vaccine) and BCG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 16, 2014)
3
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2008)
25
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00671554
Other Study ID Numbers  ICMJE CC/ORI 07-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prisma Health-Upstate
Study Sponsor  ICMJE Prisma Health-Upstate
Collaborators  ICMJE Oncolix, Inc.
Investigators  ICMJE
Study Director: Thomas E Wagner, PhD Greenville Hospital System
PRS Account Prisma Health-Upstate
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP