Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00005812|
Recruitment Status : Terminated (No objective response documented, protocol terminated after 12 patients.)
First Posted : January 27, 2003
Last Update Posted : May 14, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumors Central Nervous System Tumors Leptomeningeal Metastases||Drug: temozolomide||Phase 2|
- 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 (e.g., 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases|
|Study Start Date :||January 2000|
|Primary Completion Date :||May 2004|
|Study Completion Date :||May 2004|
Oral temozolomide 75 mg/m2/day for 6 weeks, followed by 4 week break. Cycles will continue until:
- Objective Response [ Time Frame: Every 6 weeks ]Response will be assessed clinically, cytologically, and radiographically.
- Pharmacokinetics [ Time Frame: Every 6 weeks ]Drug levels in cerebrospinal fluid assessed every 6 weeks
- Survival [ Time Frame: every 6 weeks ]
- Quality of Life [ Time Frame: Baseline, weekly during cycle 1, before each additional cycle ]FACT-Br
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): NCT00005812
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|Study Chair:||Thomas H. Davis, MD||Norris Cotton Cancer Center|