Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003462
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
1999-11-01
Brief Title:
Intrathecal Busulfan in Treating Patients With Recurrent Refractory or Metastatic Leptomeningeal Tumors
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase I Study of Intrathecal Spartaject-Busulfan in Patients With 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 Giving drugs into the thin space between the lining of the spinal cord and brain may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of intrathecal busulfan in treating patients with recurrent refractory or metastatic leptomeningeal tumors
PURPOSE Phase I trial to study the effectiveness of intrathecal busulfan in treating patients with recurrent refractory or metastatic leptomeningeal tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of intrathecal busulfan by a limited escalation dosage schedule in patients with recurrent or refractory leptomeningeal tumors
Determine the cerebrospinal fluid and serum pharmacokinetics of busulfan administered via intralumbar or intraventricular routes in these patients
OUTLINE This is dose-escalation study
Patients receive intrathecal busulfan via intralumbar or intraventricular routes twice a week for 2 weeks 4 treatments Any patient with objective or significant clinical response may continue treatment by receiving the same dose once a week for 2 consecutive weeks once a week every other week for 3 weeks 2 treatments and then once a month thereafter until disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of intrathecal busulfan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 12 weeks for 1 year or until disease progression
PROJECTED ACCRUAL A total of 5-20 patients will be accrued for this study within 1-2 years
Determine the maximum tolerated dose of intrathecal busulfan by a limited escalation dosage schedule in patients with recurrent or refractory leptomeningeal tumors
Determine the cerebrospinal fluid and serum pharmacokinetics of busulfan administered via intralumbar or intraventricular routes in these patients
OUTLINE This is dose-escalation study
Patients receive intrathecal busulfan via intralumbar or intraventricular routes twice a week for 2 weeks 4 treatments Any patient with objective or significant clinical response may continue treatment by receiving the same dose once a week for 2 consecutive weeks once a week every other week for 3 weeks 2 treatments and then once a month thereafter until disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of intrathecal busulfan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 12 weeks for 1 year or until disease progression
PROJECTED ACCRUAL A total of 5-20 patients will be accrued for this study within 1-2 years
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 |
|---|---|---|---|
| CDR0000066494 | OTHER | NCI | None |
| DUMC-0672-03-3R5 | None | None | None |
| DUMC-000672-02-3R4 | None | None | None |
| DUMC-000672-00-3R2 | None | None | None |
| DUMC-000672-01-3R3 | None | None | None |
| DUMC-0631-99-4RI | None | None | None |
| DUMC-625-98-4 | None | None | None |
| DUMC-98045 | None | None | None |
| DUMC-FDR001519 | None | None | None |
| NCI-G98-1463 | None | None | None |