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:
Collaborator:
Oncolix, Inc.
Information provided by (Responsible Party):
Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier:
NCT00671554
First received: April 30, 2008
Last updated: May 16, 2014
Last verified: May 2014
  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: 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 Hospital System University Medical Center:

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

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 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospital System University Medical Center
Oncolix, Inc.
Investigators
Study Director: Thomas E Wagner, PhD Greenville Hospital System
  More Information

No publications provided

Responsible Party: Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier: NCT00671554     History of Changes
Other Study ID Numbers: CC/ORI 07-02
Study First Received: April 30, 2008
Results First Received: April 3, 2012
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Greenville Hospital System University Medical Center:
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
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014