Intrathecal Gemcitabine to Treat Neoplastic Meningitis, IT Gemcitabine

PHASE1TerminatedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

December 31, 2001

Primary Completion Date

July 31, 2005

Study Completion Date

April 30, 2007

Conditions
MeningitisNeoplasms
Interventions
DRUG

Gemcitabine

"Schedule~Induction: At Dose Level 1athe first cohort of patients will receive intrathecal gemcitabine on a weekly basis for a total of 6 weeks. If that is tolerated, the subsequent cohort will receive intrathecal gemcitabine on a twice-weekly basis (Dose Level 1b) for a total of 6 weeks. Subsequent cohorts (Dose Levels 2 - 6) will receive intrathecal gemcitabine on a twice weekly basis for a total of 6 weeks (12 doses).~In the absence of disease progression or DLT, patients may proceed to consolidation.~Consolidation: Intrathecal gemcitabine will be administered weekly for a total of 6 doses. The first dose of consolidation will be given 1 week after the last induction dose. In the absence of disease progression or DLT, patients may proceed to maintenance.~Maintenance: Intrathecal gemcitabine will be given twice monthly for 4 months and monthly thereafter. In the absence of progressive disease or dose-limiting toxicity, the total duration of therapy will be 1 year."

Trial Locations (5)

15213

Children's Hospital of Pittsburgh, Pittsburgh

University of Pittsburgh Cancer Institute, Pittsburgh

20892

National Cancer Institute, Bethesda

77030

Texas Children's Hospital, Houston

98105

Seattle Children's Hospital, Seattle

Sponsors
All Listed Sponsors
collaborator

University of Pittsburgh

OTHER

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Children's Hospital of Pittsburg

UNKNOWN

collaborator

Seattle Children's Hospital

OTHER

collaborator

Mayo Clinic

OTHER

collaborator

Brown University

OTHER

lead

Baylor College of Medicine

OTHER