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Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases Clinical research trials and Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases. Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases  Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases
Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases
For Condition: brain metastases,unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed extracranial primary malignancy or brain metastases - At least 1 brain metastasis with at least 1 unresected lesion that is measurable by contrast-enhanced MRI - No evidence of spinal drop metastases or spread to noncontiguous meninges - No lymphoma, small cell lung cancer, or germ cell tumor PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - At least 4 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin less than 1.5 mg/dL - SGPT and/or SGOT no greater than 2 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL - BUN no greater than 25 mg/dL Other - Able to be regularly followed - No sensory neuropathy greater than grade 2 - No other major medical illnesses that would preclude study - No neurologic or psychiatric impairments that would preclude study - No active infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use at least 1 highly effective and 1 additional effective method of contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No other concurrent chemotherapy during and for 4 weeks after study Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to head or neck - No prior stereotactic radiosurgery - Concurrent radiotherapy to extracranial sites of underlying malignancy allowed Surgery - Prior craniotomy allowed if completed within the past 10-28 days
Total Enrollment:
Location and Contact Information:
Overall Study Official:
VolkerStieber, Study Chair, Comprehensive Cancer Center of Wake Forest University
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1030
United States
Recruiting Edward Shaw 336-716-4647
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
Additional Information:
Study ID Numbers: CDR0000258057; CCCWFU-91102,NCI-5883
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049361
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
2. Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
3. Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer
4. Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors
5. Magnetic-Resonance-Guided Radiofrequency Ablation in Treating Patients With Primary Kidney Cancer, Liver Metastases, or Other Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases
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