Stage IV Melanoma Clinical Trial
Official title:
Predictive Markers of Response in a Phase II Trial of Axitinib in Advanced Melanoma
This phase II trial studies how well axitinib works in treating patients with melanoma that has spread to other places in the body or cannot be removed by surgery. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the overall response rate (ORR) to axitinib in advanced melanoma. This will
be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
SECONDARY OBJECTIVES:
I. Evaluate toxicity of axitinib as a single agent. II. Determine progression-free survival
and overall survival. III. Explore the utility of 3'-deoxy-3'-[18F] fluorothymidine-labeled
positron emission tomography (FLT-PET) as a predictive marker for response and compare to
standard radiographic imaging.
TERTIARY OBJECTIVES:
I. Examine the prognostic and predictive significance of circulating melanoma tumor cells.
II. To examine whether functionally relevant polymorphisms in axitinib-related genes
(vascular endothelial growth factor receptor [VEGFR] 1, VEGFR2 and VEGFR3) correlate with
efficacy and toxicity of axitinib in advanced melanoma.
OUTLINE:
Patients receive axitinib orally (PO) twice daily (BID). Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02107755 -
Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
| Withdrawn |
NCT01216787 -
RO4929097 in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma That Can Be Removed by Surgery
|
Phase 2 | |
| Active, not recruiting |
NCT01026324 -
Dinaciclib in Treating Patients With Stage III-IV Melanoma
|
Phase 1/Phase 2 | |
| Completed |
NCT01010984 -
LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma
|
N/A | |
| Completed |
NCT00553306 -
Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma
|
Phase 1/Phase 2 | |
| Completed |
NCT00121225 -
Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
|
Phase 2 | |
| Completed |
NCT00019448 -
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
| Active, not recruiting |
NCT03200847 -
Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03235245 -
Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib
|
Phase 2 | |
| Terminated |
NCT01875653 -
Autologous Dendritic Cell-Tumor Cell Immunotherapy for Metastatic Melanoma
|
Phase 3 | |
| Completed |
NCT01748747 -
Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery
|
Early Phase 1 | |
| Terminated |
NCT01316692 -
Aurora A Kinase Inhibitor MLN8237 in Treating Patients With Unresectable Stage III-IV Melanoma
|
Phase 2 | |
| Active, not recruiting |
NCT01120275 -
Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
| Terminated |
NCT01217411 -
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
|
Phase 1 | |
| Terminated |
NCT01166126 -
Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV
|
Phase 2 | |
| Terminated |
NCT01026051 -
Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma
|
Phase 2 | |
| Completed |
NCT01037790 -
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
|
Phase 2 | |
| Completed |
NCT00288041 -
Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
| Completed |
NCT00072163 -
Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
|
Phase 2 | |
| Completed |
NCT00074308 -
Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
|
Phase 1/Phase 2 |