Melphalan in Patients With Neoplastic Meningitis
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|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|
|Actual Primary Completion Date :||May 2001|
|Actual Study Completion Date :||May 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|