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

Primary Purpose

Melanoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Melaxin (autologous dendritoma vaccine) and BCG
Sponsored by
Prisma Health-Upstate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Dendritic cells, Cell therapy, BCG vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Center of Carolinas/Clinical Research Unit 3rd Floor

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Melaxin and BCG

Arm Description

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

Outcomes

Primary Outcome Measures

Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results.
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.
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.

Full Information

First Posted
April 30, 2008
Last Updated
May 16, 2014
Sponsor
Prisma Health-Upstate
Collaborators
Oncolix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00671554
Brief Title
Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma
Official Title
Phase II, Open-Label Trial in Patients With Stage IV Malignant Melanoma Using Melaxin as a Cancer Vaccine in Conjunction With BCG
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Due to business considerations; not due to toxicities or adverse events.
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate
Collaborators
Oncolix, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, Dendritic cells, Cell therapy, BCG vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melaxin and BCG
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
Melaxin (autologous dendritoma vaccine) and BCG
Other Intervention Name(s)
Melaxin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results.
Description
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.
Time Frame
From first vaccine to 18 months after the last injection
Secondary Outcome Measure Information:
Title
Tumor Response Measured by RECIST Criteria and Progression-free Survival.
Description
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.
Time Frame
From first vaccine to 18 months after the last injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas E Wagner, PhD
Organizational Affiliation
Greenville Hospital System
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Center of Carolinas/Clinical Research Unit 3rd Floor
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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