Lymphoma Clinical Trial
Official title:
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.
;
Primary Purpose: Treatment
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