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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112762 |
RATIONALE: Drugs used in chemotherapy, such as tamoxifen, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving tamoxifen together with bortezomib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving tamoxifen together with bortezomib works in treating patients with recurrent gliomas.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: bortezomib Drug: tamoxifen citrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Tamoxifen and Bortezomib in Patients With Recurrent High-Grade Gliomas |
Estimated Enrollment: | 76 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are stratified according to disease (glioblastoma multiforme vs anaplastic glioma).
Patients receive oral tamoxifen twice daily on days 1-42 and bortezomib IV on days 3, 6, 10, 13, 24, 27, 31, and 34. Treatment repeats every 42 days for up to 9 courses in the absence of disease progression or unacceptable toxicity. After 9 courses of treatment, patients who continue to benefit from study treatment and who experience no unacceptable toxicity may receive additional courses of treatment at the investigator's discretion.
After completion of study treatment, patients are followed within 2 weeks and then annually thereafter.
PROJECTED ACCRUAL: A total of 46-76 patients (27-40 in stratum 1 and 19-36 in stratum 2) will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed high-grade glioma, including any of the following:
Anaplastic glioma, including any of the following types:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Howard A. Fine, MD | NCI - Neuro-Oncology Branch |
Responsible Party: | NCI - Neuro-Oncology Branch ( Howard A. Fine ) |
Study ID Numbers: | CDR0000429542, NCI-05-C-0137 |
Study First Received: | June 2, 2005 |
Last Updated: | May 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00112762 History of Changes |
Health Authority: | Unspecified |
adult anaplastic astrocytoma adult gliosarcoma adult glioblastoma adult anaplastic oligodendroglioma |
adult mixed glioma recurrent adult brain tumor adult giant cell glioblastoma |
Glioblastoma Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Central Nervous System Neoplasms Selective Estrogen Receptor Modulators Hormones Estrogen Receptor Modulators Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Nervous System Neoplasms Estrogens Estrogen Antagonists |
Astrocytoma Antineoplastic Agents, Hormonal Bortezomib Citric Acid Tamoxifen Recurrence Protease Inhibitors Neuroectodermal Tumors Brain Neoplasms Citrate Oligodendroglioma Gliosarcoma Neoplasms, Glandular and Epithelial |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Neoplasms, Nerve Tissue Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Central Nervous System Neoplasms Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Glioma |
Nervous System Neoplasms Estrogen Antagonists Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Nervous System Diseases Bortezomib Enzyme Inhibitors Tamoxifen Pharmacologic Actions Protease Inhibitors Neuroectodermal Tumors Neoplasms Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |