Ignite Creation Date:
2024-05-05 @ 11:22 AM
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
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
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 |