Viewing Study NCT00002750



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Last Modification Date: 2024-10-26 @ 9:03 AM
Study NCT ID: NCT00002750
Status: COMPLETED
Last Update Posted: 2013-02-20
First Post: 1999-11-01

Brief Title: Melphalan in Patients With Neoplastic Meningitis
Sponsor: Duke University
Organization: Duke University

Study Overview

Official Title: Phase I of Intrathecal Melphalan in Patients With Recurrent Neoplastic Meningitis
Status: COMPLETED
Status Verified Date: 2013-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CDR0000064684 OTHER NCI None
DUMC-2117-00-11R8 None None None
DUMC-1631-96-11R4 None None None
DUMC-1728-97-11R5 None None None
DUMC-1818-98-11R6 None None None
DUMC-1961-99-11R7 None None None
NCI-V96-0869 None None None