Clinical trial NCT00671554: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Melanoma
Keywords: Melanoma
Dendritic cells
Cell therapy
BCG vaccine
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Oncolix, Inc.
First posted: 2008-05-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results.
timeFrame: From first vaccine to 18 months after the last injection
Secondary outcomes:
measure: Tumor Response Measured by RECIST Criteria and Progression-free Survival.
timeFrame: From first vaccine to 18 months after the last injection
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Cancer Center of Carolinas/Clinical Research Unit 3rd Floor
state: South Carolina
Study officials:
affiliation: Greenville Hospital System
name: Thomas E Wagner, PhD
role: STUDY_DIRECTOR
References: