Melanoma
Conditions
Keywords
Melanoma, Dendritic cells, Cell therapy, BCG vaccine
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.
Interventions
BIOLOGICALMelaxin (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.
Sponsors
Oncolix, Inc.
Prisma Health-Upstate
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results. | From first vaccine to 18 months after the last injection | 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
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response Measured by RECIST Criteria and Progression-free Survival. | From first vaccine to 18 months after the last injection | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Melaxin Melaxin vaccine in conjunction with Bacillus Calmette-Guerin (BCG) | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease progression | 3 |
Baseline characteristics
| Characteristic | Melaxin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 70 years STANDARD_DEVIATION 5.29 |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 2 / 3 |
Outcome results
Primary
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.
Time frame: From first vaccine to 18 months after the last injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Melaxin | Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results. | 0 participants |
Secondary
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.
Time frame: From first vaccine to 18 months after the last injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Melaxin | Tumor Response Measured by RECIST Criteria and Progression-free Survival. | 0 participants |