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This study will see how these two commonly used treatments (Everolimus and Panobinostat) work together in treating kidney cancer. These two drugs have already progressed through the earliest types of research trials, such as a dose finding trial. We will combine these drugs at doses that were found to be safe when given alone, and will watch participants carefully to determine how well this drug combination is working to control your kidney cancer.
The tyrosine kinase inhibitors sunitinib and sorafenib which target the VEGF pathway are now standard of care for renal cell carcinoma patients and are used as first-line agents.
mTOR inhibitors which have been shown to have direct antitumor effects against renal cell carcinoma cells and also decrease angiogenesis by downregulation of HIF-1ά are another promising class of agents in renal cell carcinoma. Recently, the mTOR inhibitor temsirolimus was approved as a first-line agent for metastatic renal cell carcinoma in patients with decreased performance status. An improvement in overall-survival was seen when compared to the interferon alpha treatment group.
We have recently shown in preclinical studies that HDAC inhibitors induce HIF-1ά inhibition by increased acetylation and polyubiquitination and subsequently increased degradation. Furthermore, in preclinical models we have demonstrated the in vivo and in vivo antiangiogenic activity for the single agent LBH589.
Based on these data, we hypothesized that the combination of a HDAC inhibitor and an mTOR inhibitor may have greater antiangiogenic and antitumor activity than single agents in a renal cell carcinoma model.
Taken together, these data suggests that the antiangiogenic activity of the HDAC inhibitor LBH589 and its direct antitumor effect may increase the therapeutic effect of RAD001, further delay disease progression and increase progression-free survival in patients with metastatic renal cell carcinoma (RCC). With this clinical trial, we will test for the efficacy of this particular combination as second line treatment in patients with metastatic renal cell carcinoma progressing after prior cytokine and /or tyrosine kinase inhibitor treatment.
This is a dose escalation study. The Phase II dose will be based upon Phase I findings. Patients will be allowed to remain on therapy provided that they are tolerating therapy and do not develop progressive disease.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Renal Cell Carcinoma
LBH589 (Panobinostat) and RAD001 (Everolimus)
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Published on BioPortfolio: 2014-08-27T03:17:06-0400
The goal of Phase 1 of this clinical research study is to learn the highest tolerable dose of the combination of LBH589 (panobinostat) and RAD001 (everolimus) that can be given to patients...
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A heterogeneous group of sporadic or hereditary carcinoma derived from cells of the KIDNEYS. There are several subtypes including the clear cells, the papillary, the chromophobe, the collecting duct, the spindle cells (sarcomatoid), or mixed cell-type carcinoma.
An autosomal dominant disorder caused by mutations in a tumor suppressor gene. This syndrome is characterized by abnormal growth of small blood vessels leading to a host of neoplasms. They include HEMANGIOBLASTOMA in the RETINA; CEREBELLUM; and SPINAL CORD; PHEOCHROMOCYTOMA; pancreatic tumors; and renal cell carcinoma (see CARCINOMA, RENAL CELL). Common clinical signs include HYPERTENSION and neurological dysfunctions.
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
A rare tumor of the female genital tract, most often the ovary, formerly considered to be derived from mesonephric rests. Two varieties are recognized: (1) clear cell carcinoma, so called because of its histologic resemblance to renal cell carcinoma, and now considered to be of muellerian duct derivation and (2) an embryonal tumor (called also ENDODERMAL SINUS TUMOR and yolk sac tumor), occurring chiefly in children. The latter variety may also arise in the testis. (Dorland, 27th ed)
A carcinoma arising from MERKEL CELLS located in the basal layer of the epidermis and occurring most commonly as a primary neuroendocrine carcinoma of the skin. Merkel cells are tactile cells of neuroectodermal origin and histologically show neurosecretory granules. The skin of the head and neck are a common site of Merkel cell carcinoma, occurring generally in elderly patients. (Holland et al., Cancer Medicine, 3d ed, p1245)
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