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Phase I of Intrathecal Melphalan in Patients With Recurrent Neoplastic Meningitis
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of melphalan in patients with persistent or recurrent neoplastic meningitis.
OBJECTIVES: I. Determine the maximum tolerated dose of intrathecal melphalan (L-PAM) in patients with neoplastic meningitis. II. Determine the CSF and serum pharmacokinetics of L-PAM administered via an Ommaya reservoir to these patients. OUTLINE: This is a dose escalation study. Patients receive melphalan (L-PAM) intrathecally (IT) via lumbar puncture or Ommaya reservoir twice a week for 2 weeks. Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 4 of 6 patients experience dose-limiting toxicity. At least 3 patients receive L-PAM via Ommaya reservoir at the MTD. Patients with objective or significant clinical response may receive additional L-PAM IT once a week for 2 consecutive weeks, every other week for 2 doses, and then monthly thereafter. Patients are followed every 12 weeks for 1 year or until disease progression. PROJECTED ACCRUAL: A minimum of 3 children and 3 adults per dose level will be accrued for this study.
Age
3 - No limit years
Sex
ALL
Healthy Volunteers
No
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Start Date
December 1, 1992
Primary Completion Date
May 1, 2001
Completion Date
May 1, 2001
Last Updated
February 20, 2013
6
ESTIMATED participants
melphalan
DRUG
Lead Sponsor
Duke University
NCT00106925
NCT06311227
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