Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Temozolomide

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will be treated with a combination of temozolomide at 75 mg/m2/day for six continuous weeks, followed by a two-week rest period and bevacizumab 10 mg/kg every 2 weeks without interruption. Cycles will be repeated every 8 weeks. Patients will be restaged every 8 weeks.

Temozolomide 75mg/m2 for six continuous weeks

Bevacizumab 10mg/kg every 2 weeks without interruption

Jose Lutzky, MD

This research is being done because melanoma in the brain is very difficult to treat because it does not respond to radiation or to chemotherapy, such as temozolomide. One of the reasons for this is that the melanoma can make chemicals that signal the brain to provide new blood vessels for the tumor. The main signal is called VEGF. Bevacizumab is an antibody that blocks VEGF. The investigators want to see if the combination of bevacizumab and temozolomide will stop the melanoma from growing.

This study proposes the use of a combination of temozolomide and bevacizumab in a carefully selected group of patients with metastatic melanoma to the brain. This combination has been tested in primary brain tumors and in melanoma not involving the brain. The 6-week on, 2-week off low-dose schedule proposed in this trial capitalizes on preclinical data demonstrating that temozolomide inhibits angiogenesis at low, non-toxic doses that correspond to the plasma concentrations achieved by an oral administration, a so-called 'metronomic' scheduling. The precise mechanism of its antiangiogenic action remains to be elucidated. This potential synergistic mechanism, together with the bulk of evidence for activity presented above suggests that the combination will be well-tolerated, safe and possibly more effective.

Temozolomide Plus Bevacizumab in Patients With Metastatic Melanoma Involving the Central Nervous System

A Phase II Trial of Temozolomide Plus Bevacizumab in Patients With Metastatic Melanoma Involving the Central Nervous System

Northern California Melanoma Center

Mt. Sinai Medical Center, Miami

Principal Investigator Jose Lutzky, M.D.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Temozolomide Plus Bevacizumab in Patients With Metastatic Melanoma Involving the Central Nervous System	NCT01048554	Melanoma	Temozolomide Bevacizumab	18 Years - 90 Years	Mt. Sinai Medical Center, Miami
Temozolomide Plus Bevacizumab in Patients With Metastatic Melanoma Involving the Central Nervous System	NCT01048554	Melanoma	Temozolomide Bevacizumab	18 Years - 90 Years	Mt. Sinai Medical Center, Miami

Spots Global Cancer Trial Database for melanoma with brain mets