Temozolomide in Treating Patients With Invasive Pituitary Tumors
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with invasive pituitary tumors.
Brain and Central Nervous System Tumors
Genetic: DNA methylation analysis
Genetic: microarray analysis
Genetic: protein expression analysis
Genetic: proteomic profiling
Other: laboratory biomarker analysis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Temozolomide Treatment in Patients With Invasive Pituitary Tumors|
- Change from baseline of pituitary tumor control as assessed by MRI at 3, 6, 9, and 12 months [ Time Frame: 1 year ]
- Change in Tumor response rate (complete response or partial response) from baseline as assessed by RECIST criteria at 3, 6, 9, and 12 months [ Time Frame: 1 year ]
- Rebound tumor growth as assessed by MRI at 6 months after completion of treatment [ Time Frame: 6 months ]
- Biochemical control as assessed by measurement of hormones secreted in excess by the pituitary tumor at baseline, at 3, 6, 9, and 12 months during treatment, and then at 2 months after completion of treatment [ Time Frame: 14 months ]
- Pituitary function as assessed by standard pituitary function tests at baseline and at 6 months and 12 months [ Time Frame: 1 year ]
- Safety and tolerability of temozolomide as assessed by NCI CTC v2.0 at screening, baseline, and then monthly until study completion [ Time Frame: 1 year ]
- Overall quality of life as assessed by Karnofsky performance status questionnaire periodically during study [ Time Frame: 1 year ]
|Study Start Date:||December 2009|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
- To assess the effect of temozolomide on pituitary tumor growth in patients with invasive pituitary tumors.
- To assess the effect of temozolomide on pituitary tumor response and the duration of tumor response in these patients.
- To assess the effect of temozolomide on pituitary tumor hormone secretion in these patients.
- To assess the effect of temozolomide on other aspects of pituitary function in these patients.
- To assess the overall safety and tolerability of temozolomide in these patients.
- To assess the overall quality of life of patients treated with temozolomide.
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of 12 courses, patients achieving a complete or partial tumor response may continue to receive temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples are collected periodically to assess methylation status of the methyl-guanine methyl-transferase promoter (MGMT) gene and to quantitate immunocytochemical expression of the tumor suppressor proteins p53, p16, and p27. Tissue samples are also analyzed by microarray and proteomics to determine a genetic "signature" of invasive vs non-invasive pituitary tumors and to determine if this signature correlates with response to temozolomide. Blood samples are also periodically for biomarker laboratory studies.
Patients complete a quality of life questionnaire periodically.
After completion of study therapy, patients are followed for 28 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601289
|Study Chair:||Anthony Heaney, MD||Jonsson Comprehensive Cancer Center|