Clinical Trial: Temozolomide in Treating Patients With Invasive Pituitary Tumors

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: An Open Label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Temozolomide Treatment in Patients With Invasive Pituitary Tumors

Brief Summary:

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.


Detailed Summary:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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
Sponsor: Jonsson Comprehensive Cancer Center

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

  • Pituitary tumor control as assessed by MRI at baseline and at 3, 6, 9, and 12 months
  • Tumor response rate (complete response or partial response) as assessed by RECIST criteria at baseline and at 3, 6, 9, and 12 months
  • Duration of tumor response as assessed by RECIST criteria at baseline and at 3, 6, 9, and 12 months
  • Rebound tumor growth as assessed by MRI at 6 months after completion of treatment


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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
  • Pituitary function as assessed by standard pituitary function tests at baseline and at 6 months and 12 months
  • Safety and tolerability of temozolomide as assessed by NCI CTC v2.0 at screening, baseline, and then monthly until study completion
  • Overall quality of life as assessed by Karnofsky performance status questionnaire periodically during study


Information By: Jonsson Comprehensive Cancer Center

Dates:
Date Received: January 25, 2008
Date Started: December 2009
Date Completion:
Last Updated: July 27, 2012
Last Verified: July 2012