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

NCT00671554 | Terminated Phase 1 Results

• 1 other identifier: CC/ORI 07-02
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

Melanoma; Dendritic cells; Cell therapy; BCG vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  From first vaccine to 18 months after the last injection

Secondary Outcomes (1)

• Tumor Response Measured by RECIST Criteria and Progression-free Survival.

  From first vaccine to 18 months after the last injection

Study Arms (1)

Melaxin and BCG

EXPERIMENTAL

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

Interventions

Melaxin (autologous dendritoma vaccine) and BCG 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.

Also known as: Melaxin

Melaxin and BCG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Oncolix, Inc.: collaborator

Study Sites (1)

Cancer Center of Carolinas/Clinical Research Unit 3rd Floor

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Joe Stephenson, MD
• Organization: Greenville Hospital System

joe.stephenson@usoncology.com

864-455-3600

Study Officials

• Thomas E Wagner, PhD

  Greenville Hospital System

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 5, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 4, 2014
• Results First Posted: June 4, 2014

Record last verified: 2014-05

Locations

US (1)