A Phase 1/2 interventional study of Melaxin (autologous dendritoma vaccine) and BCG in Melanoma, sponsored by Prisma Health-Upstate. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-04.
Sponsored by Prisma Health-Upstate · Phase 1/2, Interventional, and Treatment
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.
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.
3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.
This study's enrollment of 3 is below the median of 38 across 2,400 interventional studies indexed under Melanoma.
Browse Melanoma studies →Prisma Health-Upstate is the lead sponsor of 76 studies on the registry; 7 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
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Exclusion Criteria:
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
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
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
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
| Milestone | Melaxin |
|---|---|
| Started | 3 |
| Completed | 0 |
| Not completed | 3 |
| Withdrew: Disease progression | 3 |
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.
| participants | Melaxin |
|---|---|
| Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results. | 0 |
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.
| participants | Melaxin and BCG |
|---|---|
| Tumor Response Measured by RECIST Criteria and Progression-free Survival. | 0 |
Collected over first dose to 6 weeks after last dose. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Melaxin | — | 2/3 (66.7%) | 3/3 (100%) |
| Event | Melaxin |
|---|---|
| Brain MetastasisNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/3 |
| injection site reactionsSkin and subcutaneous tissue disorders | 2/3 |
| Death due to disease progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/3 |
| Post-Operative meningitisNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/3 |
| Post-operative wound infectionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/3 |
| Event | Melaxin |
|---|---|
| nauseaGastrointestinal disorders | 2/3 |
| fatigueGeneral disorders | 2/3 |
| Injection site reactionsSkin and subcutaneous tissue disorders | 2/3 |
| Age, Categorical(Participants) | Melaxin |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 2 |
| Age, Continuous(years) | Melaxin |
|---|---|
| Mean | 70 ± 5.29 |
| Sex: Female, Male(Participants) | Melaxin |
|---|---|
| Female | 1 |
| Male | 2 |
| Region of Enrollment(participants) | Melaxin |
|---|---|
| United States | 3 |
The record gives a start of Apr 2008, a primary completion of Feb 2009 and a completion of Mar 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2014, 5 years 4 months after primary completion.
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This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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