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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00601289 |
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.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: temozolomide Procedure: DNA methylation analysis Procedure: gene expression profiling Procedure: laboratory biomarker analysis Procedure: protein expression analysis Procedure: proteomic profiling |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | An Open Label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Temozolomide Treatment in Patients With Invasive Pituitary Tumors |
Estimated Enrollment: | 20 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinically demonstrable invasive pituitary macroadenoma, including any of the following subtypes:
Must have biochemical evidence of any of the following:
Previously assessed by radiosurgery and meets ≥ 1 of the following criteria:
Must have a normal visual field evaluation by Goldman perimetry
Hypopituitarism allowed as evidenced by any or all of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
Los Angeles, California, United States, 90095-1781 | |
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 |
Study Chair: | Anthony Heaney, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000577534, UCLA-06-12-080, SPRI-UCLA-06-12-080, 07-05-077-01 |
Study First Received: | January 25, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00601289 |
Health Authority: | Unspecified |
pituitary chromophobe adenoma recurrent pituitary tumor ACTH-producing pituitary tumor growth hormone-producing pituitary tumor prolactin-producing pituitary tumor |
pituitary basophilic adenoma pituitary eosinophilic adenoma prolactin secreting adenoma nonfunctioning pituitary tumor |
Hypothalamic Diseases Pituitary Diseases Endocrine System Diseases Central Nervous System Diseases Central Nervous System Neoplasms Pituitary Neoplasms Prolactinoma Brain Diseases |
Temozolomide Supratentorial Neoplasms Recurrence Brain Neoplasms Endocrinopathy Adenoma Nervous System Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Hypothalamic Neoplasms Nervous System Diseases Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |