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Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System Clinical research trials and Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System. Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System clinical trial. Human subjects often receive the most effective healthcare possible for their Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System  Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System
Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System
For Condition: Recurrent Melanoma,brain metastases,Stage 4 Melanoma
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as temozolomide, 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. Combining temozolomide with radiation therapy may make the tumor cells more sensitive to radiation therapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have stage IV malignant melanoma with measurable and unresectable cancer involving the central nervous system.
Details: OBJECTIVES: Primary - Determine the response rate in patients with stage IV malignant melanoma with measurable and unresectable disease involving the central nervous system treated with temozolomide and radiotherapy. Secondary - Determine the safety of this regimen in these patients. - Determine the survival of patients treated with this regimen. - Determine the effect of this regimen on performance status and mental status of these patients. - Determine the response of extra-cranial disease in patients treated with this regimen. OUTLINE: Patients receive concurrent chemoradiotherapy comprising whole brain radiotherapy daily on days 1-5, 8-13, and 16-21 and oral temozolomide daily on days 1-5. Subsequent treatment with temozolomide repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 27-65 patients will be accrued for this study within 13-17 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IV malignant melanoma with measurable and unresectable disease involving the central nervous system - Study entry within 14 days of diagnosis of brain metastases - Recursive partitioning analysis class I or II - Disease for which no known standard therapy exists that is potentially curative or proven capable of extending life expectancy - No meningeal carcinomatosis based on imaging studies or on positive results from CSF analysis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.0 g/dL Hepatic - AST no greater than 3 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 3 times ULN Renal - Creatinine no greater than 1.5 times ULN Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No concurrent uncontrolled infection - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer treated with local resection only - No prior allergy or intolerance to dacarbazine - No hypersensitivity to temozolomide or any of its components PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior biologic therapy - More than 4 weeks since prior immunotherapy Chemotherapy - No prior temozolomide - More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy - Concurrent steroids allowed if dose stable for at least 7 days prior to CNS imaging Radiotherapy - More than 4 weeks since prior radiotherapy - No prior radiotherapy to more than 15% of the bone marrow - No prior radiotherapy to the head and neck area - No prior radiosurgery Surgery - See Radiotherapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdwardCreagan, , Mayo Clinic Cancer Center
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Atlanta Regional *Recruiting*
Atlanta, Georgia, 30342-1701
United States
Recruiting Thomas Seay 404-851-2340
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54301
United States
Recruiting Anthony Jaslowski 920-884-3135
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
CentraCare Health Plaza *Recruiting*
St. Cloud, Minnesota, 56303
United States
Recruiting Harold Windschitl 320-229-5199
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting Mark Olsen 918-499-2000
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Jane Raymond 412-359-6147
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Steven Alberts 507-284-2511
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Muhammad Salim 306-766-2203
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Altru Cancer Center *Recruiting*
Grand Forks, North Dakota, 58201
United States
Recruiting Todor Dentchev 701-780-6363
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Daniel Nikcevich 218-786-3625
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Additional Information:
Study ID Numbers: CDR0000327811; NCCTG-N0274
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068666
Other Recurrent Melanoma Studies:
1. Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
2. Interferon alfa and Thalidomide in Treating Patients With Stage IV Melanoma
3. Vaccine Therapy in Treating Patients With Metastatic Melanoma
4. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
5. Carboplatin and Temozolomide in Treating Patients With Unresectable or Metastatic Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Florida Clinical Trials
Other Jacksonville Clinical Trials
Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System
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