Melphalan in Patients With Neoplastic Meningitis
|ClinicalTrials.gov Identifier: NCT00002750|
Recruitment Status : Completed
First Posted : May 24, 2004
Last Update Posted : February 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Leukemia Lymphoma Ovarian Cancer||Drug: melphalan||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Official Title:||Phase I of Intrathecal Melphalan in Patients With Recurrent Neoplastic Meningitis|
|Study Start Date :||December 1992|
|Primary Completion Date :||May 2001|
|Study Completion Date :||May 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002750
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Henry S. Friedman, MD||Duke Cancer Institute|