Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases Clinical research trials and Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases. Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases clinical trial. Subjects often receive the most expert healthcare possible for their Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.

Home > "T" Clinical Trials Conditions > Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases



Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

For Condition: brain metastases
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , 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. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide and vinorelbine in treating patients who have recurrentbrain metastases.
Details: OBJECTIVES: - Determine the maximum tolerated dose of vinorelbine when administered in combination with temozolomide in patients with recurrent brain metastases. - Determine the safety and feasibility of this treatment regimen in these patients. - Determine the efficacy of this treatment regimen, in terms of objective radiographic response and overall and progression-free survival, in these patients. OUTLINE: This is a dose-escalation study of vinorelbine. Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and oral temozolomide once daily on days 1-7 and 15-21. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 20-35 patients will be treated at that dose level. Patients are followed every 3-4 months. PROJECTED ACCRUAL: A minimum of 3 patients will be accrued for the phase I portion of this study and 20-35 patients will be accrued for the phase II portion of this study within 2 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor with metastases to the brain - Evaluable disease in brain by MRI or CT scan PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 8 weeks 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 times upper limit of normal (ULN) - SGOT and SGPT no greater than 3 times ULN - Alkaline phosphatase no greater than 2 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 - HIV negative - No AIDS-related illness - No nonmalignant systemic disease - No psychiatric condition that would preclude study - No acute infection requiring IV antibiotics - No frequent vomiting or medical condition that would preclude oral medication intake (i.e., partial bowel obstruction) PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biologic therapy or immunotherapy Chemotherapy: - At least 4 weeks since prior chemotherapy - No prior temozolomide, dacarbazine, or vinorelbine - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior external beam radiotherapy - At least 8 weeks since prior stereotactic radiosurgery - Concurrent focal radiotherapy for progressive bony disease allowed if brain metastases are stable or responding Surgery: - At least 2 weeks since prior brain biopsy, craniotomy, or other surgery Other: - Recovered from all prior therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
LaurenAbrey,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Lauren  Abrey 212-639-5122


Additional Information:
Study ID Numbers:  CDR0000069035;  MSKCC-01088A,NCI-G01-2025
Study Start Date: 
Record last reviewed: November 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026494

Other Brain Metastases Studies:
1. Radiation Therapy With or Without Temozolomide in Treating Patients With Non-Small Cell Lung Cancer That is Metastatic to the Brain

2. Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain

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

4. Temozolomide in Treating Patients With Brain Metastases

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

Related Studies:

Other brain metastases Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials

Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases
Modify your Search

  Other brain metastases Clinical Trials
  Other New York Clinical Trials
  Other New York City 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