Status:
TERMINATED
Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma
Lead Sponsor:
Prisma Health-Upstate
Collaborating Sponsors:
Oncolix, Inc.
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 m...
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, t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00671554
Start Date
April 1 2008
End Date
March 1 2009
Last Update
June 4 2014
Active Locations (1)
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1
Cancer Center of Carolinas/Clinical Research Unit 3rd Floor
Greenville, South Carolina, United States, 29605