A Phase I Dose Escalation Study of Intrathecal DepoFoam Encapsulated Cytarabine (DTC 101) in Pediatric Patients With Advanced Meningeal Malignancies
OBJECTIVES: I. Determine the qualitative or quantitative toxic effects and tolerability of
liposomal cytarabine (Depofoam encapsulated cytarabine; DTC 101) in pediatric patients with
recurrent or refractory meningeal malignancies. II. Define a safe dose of DTC 101 in these
patients for future clinical studies. III. Determine the plasma and CSF pharmacokinetics of
DTC 101 in these patients.
OUTLINE: This is a dose escalation, multicenter study. Patients are placed in one of three
age-related strata: stratum 1, 3 to 21 years of age; stratum 2, at least 2 but less than 3
years of age; stratum 3, at least 1 but less than 2 years of age. Patients receive an
induction dose of intrathecal liposomal cytarabine (Depofoam encapsulated cytarabine; DTC
101) administered once every 2 weeks for 2 courses. Patients who have achieved a partial
response or received significant clinical benefit with stable disease may receive a third
induction dose of DTC 101, 2 weeks following the second dose. In the absence of progressive
disease, patients can proceed to consolidation therapy. During consolidation therapy,
intrathecal DTC 101 is administered once every 4 weeks for 2 courses, beginning 4 weeks
after the last induction dose. Patients experiencing a complete or significant response can
proceed to maintenance therapy. Patients receive a maintenance dose of intrathecal DTC 101
once every 8 weeks for a total of 6 doses, beginning 4 weeks after the second consolidation
dose. At least 3 patients are evaluated at each dose level. Dose escalation to the next
level proceeds when a minimum of 3 patients per cohort has successfully completed induction
therapy and been evaluated. Patients will be followed at 1, 2, 3, 6, 9, and 12 months post
treatment, until relapse or death.
PROJECTED ACCRUAL: A minimum of 12-15 patients will be accrued for each stratum over 18 to
24 months.
Interventional
Primary Purpose: Treatment
John E. Gait, MD
Study Chair
Pacira Pharmaceuticals, Inc
United States: Federal Government
CDR0000065754
NCT00003073
February 1997
Name | Location |
---|---|
Stanford University Medical Center | Stanford, California 94305-5408 |
Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
Texas Children's Cancer Center | Houston, Texas 77030-2399 |
University of Texas Southwestern Medical Center at Dallas | Dallas, Texas 75235-8897 |