Other Clinical Trial - Radiation Therapy Plus Thalidomide & Temozolomide

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

OBJECTIVES: - Determine the overall median survival time of patients with newly diagnosed brain metastases treated with whole-brain radiotherapy in combination with thalidomide and temozolomide. - Determine the radiographic response rate, median time to tumor progression, and median time to neurologic response and progression in patients treated with this regimen. - Determine the cause of death of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. - Assess quality of life of patients treated with this regimen. 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. ;

Study Design

Related Conditions & MeSH terms

Brain and Central Nervous System Tumors
Central Nervous System Neoplasms
Neoplasms
Nervous System Neoplasms
Unspecified Adult Solid Tumor, Protocol Specific

Clinical Trial Details

NCT number	NCT00049361
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Completed
Phase	Phase 2
Start date	January 1, 2004
Completion date	December 7, 2004

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms