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Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors Clinical research trials and Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors. Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors clinical trial. Subjects frequently obtain the most expert healthcare possible for their Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors  Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors
Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors
For Condition: childhood central nervous system germ cell tumor,extragonadal germ cell tumor,adult central nervous system germ cell tumor,childhood mature and immature teratomas
Status: Recruiting
Sponsor(s): Mayo Clinic 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of cisplatin and etoposide in treating patients with CNS tumors.
Details: OBJECTIVES: - Determine the response rate of patients with newly diagnosed CNS germ cell tumors treated with cisplatin and etoposide. - Determine the survival of patients with CNS germ cell tumors treated with cisplatin and etoposide followed by cranial radiotherapy. - Determine endocrine and cognitive function in these patients before and after receiving this regimen. OUTLINE: Patients are stratified by histology (germinoma vs nongerminoma). Patients receive cisplatin IV over 4 hours followed by etoposide IV over 30-60 minutes on days 1-5. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses, patients with nongerminoma who achieve complete response (CR) and all patients with germinoma proceed to radiotherapy. After completion of 4 courses, patients with nongerminoma who achieve less than CR undergo resection of any residual cranial masses, if feasible, and then proceed to radiotherapy. Patients who experience disease progression or unacceptable toxicity during chemotherapy are restaged and proceed directly to radiotherapy. Beginning a minimum of 3 weeks after completion of the last course of chemotherapy and after recovering from any toxic effects of chemotherapy, eligible patients undergo a regimen of craniospinal axis irradiation and/or localized cranial or spinal field irradiation based on histology, extent of disease, and response to chemotherapy. Patients with gross spinal meningeal disease after completion of chemotherapy undergo radiotherapy boost. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years. PROJECTED ACCRUAL: A total of 12-25 patients with germinoma will be accrued for this study within 3-6 years. A total of 12-25 patients with nongerminoma will be accrued for this study within 6-12 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven CNS germ cell tumor of 1 of the following subtypes: - CNS germinoma - Immature teratoma - Embryonal cell carcinoma - Yolk sac tumor - Endodermal sinus tumor - Choriocarcinoma OR - Pineal or suprasellar mass associated with elevated CSF alpha fetoprotein or beta-human chorionic gonadotropin allowed - Patients 18 years and over with localized pure germinomas ineligible - Evaluable CT or MRI of brain and/or spinal cord required PATIENT CHARACTERISTICS: Age: - 3 and over Hematopoietic: - Age 18 and over: - WBC at least 4,000/mm^3 - Platelet count at least 100,000/mm^3 - Under age 18: - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Not specified Renal: - Creatinine no greater than 0.3 mg/dL above upper limit of normal for age Other: - No uncontrolled infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for CNS germ cell tumor Endocrine therapy: - Concurrent corticosteroids allowed except as antiemetics Radiotherapy: - No prior cranial or spinal radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JanBuckner, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Scottsdale *Recruiting*
Scottsdale, Arizona, 85259
United States
Recruiting Tom Fitch 480-301-9875
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Kurt Jaeckle 904-953-7102
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Jan Buckner 507-284-2511
Additional Information:
Study ID Numbers: CDR0000076756; MAYO-891351,NCI-T92-0208D
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002472
Other Adult Central Nervous System Germ Cell Tumor Studies:
1. Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors
2. Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors
3. Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors
4. Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors
5. Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors
Related Studies:
Other adult central nervous system germ cell tumor Clinical Trials
Other Arizona Clinical Trials
Other Scottsdale Clinical Trials
Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors
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