Neoplasms

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Symptoms and General Pathology

Breast Neoplasms

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Meningitis

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Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Anti-Infective Agents

Antineoplastic Agents

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Cytarabine

Sorafenib

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Protein Kinase Inhibitors

Enzyme Inhibitors

This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.

Patients were to receive DepoCyt through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses.

DepoCyt

Patients received oral sorafenib at 400 mg twice a day

Edward Pan, M.D.

The purpose of this study is to determine the tolerability and side effects of oral sorafenib in combination with intrathecal DepoCyt.

After an Ommaya reservoir has been placed in the patient's head, the patient will receive DepoCyt through that reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Patients will also receive oral sorafenib at 400 mg twice a day throughout the treatment course until disease progression or death. Patients will receive brain magnetic resonance imaging (MRIs) with contrast (and whole spine, if necessary) and spinal fluid studies will be obtained every 8 weeks through the Ommaya reservoir until disease progression, death, or unacceptable toxicity. In addition, patients will have spinal fluid obtained to test for sorafenib levels at each study visit after the start of sorafenib as well as prior to sorafenib treatment for controls.

Depocyt® With Sorafenib in Neoplastic Meningitis

A Single Arm Pilot Study of Intrathecally Administered DepoCyt® With Systemic Sorafenib in the Treatment of Neoplastic Meningitis From Solid Tumors

Safety and tolerability of sorafenib with DepoCyt. Toxicities were to be reported using tables and descriptive statistics by type and grade. All patients were to be followed up until death.

Kaplan-Meier analysis of PFS was to be performed and the PFS at 6 months in the study patients were be empirically described. All patients were to be followed up until death.

Several secondary endpoints were to be analyzed in a descriptive fashion. All patients were to be followed up until death.

CSF sorafenib level was to be measured over time, and the means and standard errors of the sorafenib level were to be plotted at specific sampling time points. CSF sorafenib levels may also have been correlated with patients' PFS, OS, or cytology using descriptive statistical methods (e.g., KM analysis stratified by high vs. low CSF sorafenib levels). The log transformation of lab values were to be employed on the continuous variables whenever necessary.

CSF and serum VEGF levels were to be measured over time, and the means and standard errors of the respective VEGF levels were to be plotted at specific sampling time points. The respective VEGF levels may also have been correlated with patients' PFS, OS, or cytology using descriptive statistical methods similarly as mentioned above. The log transformation of lab values were to be employed on the continuous variables whenever necessary.

Bayer

H. Lee Moffitt Cancer Center and Research Institute

First On Study (9/10/09) to last Off Study (5/18/10)

Intrathecal DepoCyt and Oral Sorafenib

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Depocyt® With Sorafenib in Neoplastic Meningitis	NCT00964743	Neoplastic Meni...	DepoCyt Sorafenib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Depocyt® With Sorafenib in Neoplastic Meningitis	NCT00964743	Neoplastic Meni...	DepoCyt Sorafenib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for neoplastic meningitis from solid tumors