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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049361 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining whole-brain radiation therapy with thalidomide and temozolomide in treating patients who have newly diagnosed brain metastases.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Unspecified Adult Solid Tumor, Protocol Specific |
Drug: temozolomide Drug: thalidomide Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases |
Study Start Date: | January 2004 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy daily 5 days a week for 3 weeks. Beginning on the day before the first radiation treatment, patients receive oral thalidomide once daily and oral temozolomide once daily for 21 days. Patients continue to receive thalidomide daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 1 and 3 months after completing radiotherapy, and then every 3 months thereafter.
Patients are followed at 1 and 3 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 10 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Illinois | |
CCOP - Central Illinois | |
Decatur, Illinois, United States, 62526 | |
United States, North Carolina | |
CCOP - Southeast Cancer Control Consortium | |
Goldsboro, North Carolina, United States, 27534-9479 | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1030 | |
United States, South Carolina | |
CCOP - Greenville | |
Greenville, South Carolina, United States, 29615 | |
CCOP - Upstate Carolina | |
Spartanburg, South Carolina, United States, 29303 |
Study Chair: | Volker W. Stieber, MD | Wake Forest University |
Study ID Numbers: | CDR0000258057, CCCWFU-91102, NCI-5883 |
Study First Received: | November 12, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00049361 History of Changes |
Health Authority: | United States: Federal Government |
adult tumors metastatic to brain unspecified adult solid tumor, protocol specific |
Anti-Bacterial Agents Immunologic Factors Thalidomide Neoplasm Metastasis Antineoplastic Agents, Alkylating Central Nervous System Neoplasms |
Alkylating Agents Angiogenesis Inhibitors Immunosuppressive Agents Temozolomide Nervous System Neoplasms |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Thalidomide Antineoplastic Agents Physiological Effects of Drugs Central Nervous System Neoplasms Anti-Bacterial Agents Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis |
Angiogenesis Modulating Agents Growth Inhibitors Alkylating Agents Nervous System Neoplasms Growth Substances Nervous System Diseases Immunosuppressive Agents Temozolomide Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Antineoplastic Agents, Alkylating Leprostatic Agents |