This pilot clinical trial studies meclofenamate sodium in treating patients with brain metastasis from solid tumors that has come back (recurrent) or is growing, spreading, or getting worse (progressive). Meclofenamate sodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02429570.
PRIMARY OBJECTIVES:
I. To determine feasibility of a trial of meclofenamate (meclofenamate sodium) treatment for recurrent or active brain metastases.
SECONDARY OBJECTIVES:
I. Safety of meclofenamate treatment in patients with active brain metastases.
II. Intracranial progression-free survival of patients with recurrent or progressive brain metastases after meclofenamate treatment.
III. Overall survival at six months.
TERTIARY OBJECTIVES:
I. Compliance.
II. Seizure control.
III. Correlation between connexin 43 and protocadherin 7 (PCDH7) expression and intracranial progression-free survival (icPFS) and/or overall survival (OS).
OUTLINE:
Patients receive meclofenamate sodium orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up weekly for 30 days.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAdrienne Boire