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

NCT ID: NCT00671554

Last Updated: 2014-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-03-31

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Melaxin (autologous dendritoma vaccine) and BCG

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Melaxin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prisma Health-Upstate

OTHER

Sponsor Role: lead

Oncolix, Inc.

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas E Wagner, PhD

Role: STUDY_DIRECTOR

Greenville Hospital System

Locations

Cancer Center of Carolinas/Clinical Research Unit 3rd Floor

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

CC/ORI 07-02

Identifier Type: -

Identifier Source: org_study_id