Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005812
Status:
TERMINATED
Last Update Posted:
2013-05-14
First Post:
2000-06-02
Brief Title:
Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases
Status:
TERMINATED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No objective response documented protocol terminated after 12 patients
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 cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma
Detailed Description:
OBJECTIVES
Determine the objective response rate survival time and quality of life of patients with leptomeningeal metastases from a solid tumor or lymphoma when treated with oral temozolomide
Determine adverse events related to this regimen in this patient population
Measure temozolomide concentrations in CSF and serum and correlate with appropriate pharmacodynamic parameters eg response in these patients
OUTLINE Patients receive oral temozolomide daily for 6 weeks Courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression
Patients with a complete response CR receive 2 additional courses after achieving CR Patients with a CR except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response
Quality of life is assessed at baseline weekly for the first 4 weeks of therapy and then monthly thereafter
PROJECTED ACCRUAL A total of 14-24 patients will be accrued for this study
Determine the objective response rate survival time and quality of life of patients with leptomeningeal metastases from a solid tumor or lymphoma when treated with oral temozolomide
Determine adverse events related to this regimen in this patient population
Measure temozolomide concentrations in CSF and serum and correlate with appropriate pharmacodynamic parameters eg response in these patients
OUTLINE Patients receive oral temozolomide daily for 6 weeks Courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression
Patients with a complete response CR receive 2 additional courses after achieving CR Patients with a CR except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response
Quality of life is assessed at baseline weekly for the first 4 weeks of therapy and then monthly thereafter
PROJECTED ACCRUAL A total of 14-24 patients 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 |
|---|---|---|---|
| NCI-G00-1782 | None | None | None |
| DMS-9812 | None | None | None |