A Phase 1/2 interventional study of Dendritic cell vaccine plus denileukin difitox in Melanoma (Skin), sponsored by University Hospital Erlangen. Completed at 1 site in Germany. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by University Hospital Erlangen · Phase 1/2, Interventional, and Treatment
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. Biological therapies such as denileukin diftitox may be able to deliver cancer-killing substances directly to melanoma cells. Combining vaccine therapy with biological therapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining vaccine therapy with denileukin diftitox in treating patients who have stage III or stage IV melanoma.
OBJECTIVES:
OUTLINE:
Patients who show a tumor response (at least stable disease) may receive vaccination #5 and further booster vaccinations.
Patients are followed for 10 years.
PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 23 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →University Hospital Erlangen is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed locoregional or metastatic cutaneous malignant melanoma
Stage III or IV disease
HLA-A1 and/or HLA-A2 expression by serologic HLA typing
No active CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
No immunodeficiency disease
No active autoimmune disease including, but not limited to:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Safety and tolerability as assessed by clinical and laboratory evaluation at every visit
Overall survival as assessed by clinical staging (CT scan and positron emission tomography [PET]) every 3 months
Depletion of regulatory T-cells as assessed by tetramer stainings at every visit
Induction of antigen-specific immune responses as assessed by elispot and tetramer staining at every visit
Time to progression as assessed by clinical staging (CT scan and PET) every 3 months
Objective response rate as assessed by clinical staging (CT scan and PET) every 3 months
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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University Hospital Erlangen