Melanoma (Skin) Clinical Trial
Official title:
Adjuvant Vaccination With Melanoma Antigen Pulsed Dendritic Cells (DCs) in Stage III Melanoma Patients
RATIONALE: Vaccines made from dendritic cells and tumor antigen peptides or a person's tumor
cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best way to give melanoma
vaccine in treating patients with stage III melanoma after surgery to remove the lymph
nodes.
OBJECTIVES:
- Determine the feasibility of adjuvant melanoma vaccine comprising autologous dendritic
cells pulsed with tumor antigen peptides in patients with stage III melanoma following
lymphadenectomy.
- Determine the immune response (skin test of delayed-type hypersensitivity and flow
cytometric enumeration of peripheral blood CD8+ lymphocytes producing IFN-γ) to this
regimen in these patients.
- Determine clinical outcome (disease-free survival, overall survival, and adverse
events) in patients treated with this regimen.
OUTLINE: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells
(PBMCs) and bone marrow mononuclear cells. Autologous dendritic cells (DCs) prepared from
PBMCs and bone marrow mononuclear cells are exposed to various antigens and peptides, and
autologous tumor cell lysate, if available. Patients receive autologous DCs pulsed with
melanoma-associated antigen peptides, and autologous DCs pulsed with tumor lysates (if
available), subcutaneously in weeks 0, 2, 5, 8, 12, 16, 20, 26, 31, 50, and 102. Patients
with no evidence of disease may receive another booster injection 5 years after the start of
vaccination.
Blood samples are examined via flow cytometry and skin testing is performed to evaluate
immune response.
;
Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04062032 -
Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma
|
Phase 2 | |
| Completed |
NCT03620019 -
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
|
Phase 2 | |
| Active, not recruiting |
NCT03291002 -
Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC
|
Phase 1 | |
| Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
| Completed |
NCT00962845 -
Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
|
Early Phase 1 | |
| Completed |
NCT00324623 -
Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma
|
Phase 1 | |
| Completed |
NCT00096382 -
Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
| Completed |
NCT00104845 -
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
|
Phase 1 | |
| Completed |
NCT00072085 -
Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
| Completed |
NCT00089193 -
Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
|
Phase 2 | |
| Completed |
NCT00072124 -
Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma
|
Phase 3 | |
| Active, not recruiting |
NCT00039234 -
Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
|
Phase 3 | |
| Completed |
NCT00042783 -
Vaccine Therapy in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
| Completed |
NCT00049010 -
Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
|
N/A | |
| Completed |
NCT00020358 -
Vaccine Therapy in Treating Patients With Melanoma
|
Phase 2 | |
| Completed |
NCT00006385 -
Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
| Completed |
NCT00006022 -
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
|
Phase 1 | |
| Completed |
NCT00005610 -
Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
|
Phase 2 | |
| Recruiting |
NCT03767348 -
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab
|
Phase 2 | |
| Withdrawn |
NCT00006126 -
Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
|
Phase 1 |