Melanoma (Skin) Clinical Trial
Official title:
Treatment of Melanoma With Wild-type p53 and Detectable S100B Using Pentamidine: a Phase II Trial With Correlative Biomarker Endpoints
RATIONALE: Drugs used in chemotherapy, such as pentamidine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well pentamidine works in treating patients with
relapsed or refractory melanoma.
OBJECTIVES:
Primary
- To determine the response rate in patients with relapsed or refractory melanoma that
expresses wild-type p53 and S100 calcium binding protein B (S100B) treated with
pentamidine.
Secondary
- To observe the effect of this drug on the expression of S100B and p21 in tumor biopsy
samples.
- To observe the effect of this drug on S100B detectable in serum.
- To observe the time to progression in these patients.
- To assess the toxicities associated with the administration of this drug in these
patients.
OUTLINE: Patients receive pentamidine IV over 2 hours 5 days a week for 2 weeks. Courses
repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative
laboratory studies. Samples are assessed for p53 status and S100B, p53, and p21 expression by
immunohistochemistry, polymerase chain reaction, western blotting, luminescence assay, and
ELISA.
After completion of study treatment, patients are followed for 30 days.
;
| 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 |
NCT00104845 -
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV 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 |
NCT00072124 -
Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma
|
Phase 3 | |
| 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 | |
| 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 |
NCT00049010 -
Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
|
N/A | |
| Completed |
NCT00042783 -
Vaccine Therapy in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
| Completed |
NCT00006385 -
Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
| Completed |
NCT00020358 -
Vaccine Therapy in Treating Patients With Melanoma
|
Phase 2 | |
| Completed |
NCT00005610 -
Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
|
Phase 2 | |
| Completed |
NCT00006022 -
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
|
Phase 1 | |
| 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 |