|
Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin Clinical research trials and Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin. Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin clinical trial. Human subjects often get the best healthcare possible for their Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin  Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin
Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin
For Condition: stage 3 testicular cancer,recurrent ovarian germ cell tumor,stage 4 ovarian germ cell tumor,recurrent testicular cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering 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 metastatic germ cell tumors that have not responded to cisplatin.
Details: OBJECTIVES: I. Determine the efficacy of temozolomide in patients with cisplatin refractory metastatic germ cell tumors. II. Determine the safety of this treatment in these patients. PROTOCOL OUTLINE: Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study over 25 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Neurologically confirmed metastatic germ cell tumor Seminoma OR Nonseminoma - Measurable disease Abnormalities on radiograph OR Alpha fetoprotein greater than 15 ng/mL OR Beta human chorionic gonadotropin greater than 2.2 mIU/L - At least one measurable disease site that has not received prior radiotherapy - Refractory to prior cisplatin and failed, not eligible for, or refused autologous bone marrow transplantation --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics - Surgery: Not specified --Patient Characteristics-- - Age: 16 and over - Performance status: Karnofsky 70-100% - Life expectancy: At least 3 months - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,000/mm3; Platelet count at least 80,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin no greater than 1.5 times normal; Transaminases no greater than 1.5 times upper limit or normal (ULN); Alkaline phosphatase no greater than 3.0 times ULN - Renal: Creatinine no greater than 1.5 times ULN - Other: No medical conditions that would interfere with swallowing or cause excessive vomiting; No second malignancy except basal and squamous cell skin cancer; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective barrier contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertMotzer, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068058; MSKCC-00010,NCI-G00-1817
Study Start Date: February 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006043
Other Recurrent Testicular Cancer Studies:
1. Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
2. Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin
3. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
Related Studies:
Other recurrent testicular cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin
|
|
|
|
|
|
|
|
