Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain Clinical research trials and Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain health trials happen in many 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 effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain. Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain clinical trial. Subjects frequently get the best healthcare possible for their Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.

Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain

Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain



Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain

For Condition: brain metastases
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors that have spread to the brain.
Details: OBJECTIVES: I. Assess the response rate of patients with cerebral metastases who have failed or refused standard therapy when treated with temozolomide. II. Assess the safety and tolerability of this drug in these patients. III. Determine the quality of life of patients treated with this drug. IV. Determine the response rate of systemic disease outside the central nervous system in patients treated with this drug. PROTOCOL OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Treatment repeats every 10 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed on day 1 of each 10-week course. Patients are followed for 30 days. PROJECTED ACCRUAL: A total of 18-48 patients will be accrued for this study within 2 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced solid malignancy with imaging evidence of progressive brain metastases; Failed or refused surgery, whole brain radiotherapy, and/or stereotactic radiosurgery; No lymphoma; Systemic disease allowed (if uncontrolled, must be less life-threatening than brain metastases) - Bidimensionally measurable brain disease by MRI; Previously treated lesions must show progression and be measurable - No known carcinomatous meningitis --Prior/Concurrent Therapy-- - Biologic therapy: At least 2 weeks since prior biologic therapy or immunotherapy and recovered; No concurrent growth factors administered for the purpose of continuing temozolomide; No concurrent epoetin alfa - Chemotherapy: Prior adjuvant chemotherapy allowed; Prior chemotherapy for metastatic disease allowed; At least 4 weeks since prior chemotherapy except vincristine (6 weeks for nitrosoureas or mitomycin) and recovered - Endocrine therapy: Prior and concurrent steroids allowed if neurologically stable or improving; Concurrent hormonal therapy allowed for stable breast cancer - Radiotherapy: See Disease Characteristics; At least 2 weeks since prior radiotherapy or interstitial brachytherapy (4 weeks for brain radiotherapy) and recovered; No concurrent radiotherapy - Surgery: See Disease Characteristics; At least 1 week since prior surgery and recovered - Other: At least 4 weeks since prior systemic therapy; No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: More than 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); SGOT and SGPT no greater than 3 times ULN; Alkaline phosphatase no greater than 3 times ULN - Renal: Creatinine less than 1.5 times ULN; BUN less than 1.5 times ULN - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No known HIV infection; No other malignancy within the past 2 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin; No other serious medical condition; No acute infection treated with IV antibiotics; No frequent vomiting or other medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JudithFord,  Study Chair,  Jonsson Comprehensive Cancer Center

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 


Additional Information:
Study ID Numbers:  CDR0000068485;  SPRI-UCLA-0004059,NCI-G01-1919,UCLA-0004059
Study Start Date: October 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012116

Other Brain Metastases Studies:
1. Radiation Therapy in Preventing CNS Metastases in Patients With Non-Small Cell Lung Cancer

2. Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain

3. Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System

4. CCI-779 in Treating Patients With Advanced Solid Tumors

5. Adjuvant Radiation Therapy in Treating Patients With Brain Metastases

Related Studies:

Other brain metastases Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials

Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain
Modify your Search

  Other brain metastases Clinical Trials
  Other California Clinical Trials
  Other Los Angeles Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103