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Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma Clinical research trials and Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma health trials occur in many 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 effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma. Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma clinical trial. Test subjects typically receive the most expert healthcare available for their Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

Home > "T" Clinical Trials Conditions > Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma

Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma



Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma

For Condition: Stage 4 Melanoma,brain metastases,Recurrent Melanoma
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with thalidomide in treating patients who have brain metastasessecondary to melanoma.
Details: OBJECTIVES: Primary - Determine the objective response rate in patients with brain metastases secondary to melanoma treated with temozolomide and thalidomide. Secondary - Determine the toxic effects of and tolerance to this regimen in these patients. - Determine the objective response rate in extracranial metastases of patients treated with this regimen. - Determine the time to first disease progression (intra- or extracranial) in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses of therapy beyond CR. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 2 years. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 1.5 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic melanoma - Clinical evidence of brain metastases - At least 1 unidimensionally measurable brain lesion at least 2.0 cm by conventional techniques OR at least 1.0 cm by spiral CT scan or MRI - The following lesions are not considered measurable: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Lesions situated in a previously irradiated area, unless new growth is documented PATIENT CHARACTERISTICS: Age - 18 and over Performance status - CTC 0-1 Life expectancy - Not specified Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - AST and ALT no greater than 2.5 times upper limit of normal (ULN) - Lactic dehydrogenase no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal - Creatinine no greater than 2 mg/dL Cardiovascular - No history of active angina - No history of significant ventricular arrhythmia - No history of deep vein thrombosis - No myocardial infarction within the past 6 months - No acute abnormality by EKG - No uncontrolled arrhythmia Pulmonary - No history of pulmonary embolism Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 1 highly-effective and 1 additional method of contraception for 28 days before, during, and for 4 weeks after study participation - No known HIV disease - Thyroid-stimulating hormone normal - Serum anticonvulsant levels normal (for patients on anticonvulsants) - No frequent vomiting and/or any other medical condition (e.g., partial bowel obstruction) that would preclude oral medication intake - No preexisting neuropathy greater than grade 1 - No uncontrolled seizures - No other concurrent medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior cytokines - Biologic agents used as adjuvants, vaccines, and cellular therapies do not require a 4-week washout period - No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy - No more than 1 prior chemotherapy regimen - No prior chemotherapy for brain metastases - No prior continuous daily temozolomide - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy except steroids and hormones administered for non-disease-related conditions (e.g., insulin for diabetes) or for control of intracranial edema from brain metastases Radiotherapy - See Disease Characteristics - Prior whole brain radiotherapy (WBRT) allowed provided patient has progressive disease in a measurable CNS lesion - Prior stereotactic radiotherapy allowed provided patient has progressive disease in a measurable CNS lesion - At least 4 weeks since prior WBRT - At least 3 weeks since prior stereotactic radiosurgery - No concurrent radiotherapy Surgery - At least 3 weeks since prior surgical resection Other - No concurrent warfarin or heparin products or their derivatives - No concurrent antiplatelet therapy (e.g., daily aspirin, ibuprofen, or clopidogrel bisulfate) - No concurrent bisphosphonates (e.g., zoledronate)
Total Enrollment: 

Location and Contact Information:

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

UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha,  Nebraska,  68198-7680
United States
Recruiting Margaret  Kessinger 402-559-7511

Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C.,  District of Columbia,  20422
United States
Recruiting Steven  Krasnow 202-745-8178

Walter Reed Army Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20307-5000
United States
Recruiting Joseph  Drabick 202-782-6751

Florida Hospital Cancer Institute *Recruiting*
Orlando,  Florida,  32804
United States
Recruiting Jane  Crofton 407-303-2090

Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke,  Virginia,  24014
United States
Recruiting Paul  Richards 540-982-0237

Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco,  California,  94121
United States
Recruiting Patricia  Cornett 415-221-4810 ext. 3423

Western Pennsylvania Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15224
United States
Recruiting Richard  Shadduck 412-578-4355

CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem,  North Carolina,  27104-4241
United States
Recruiting James  Atkins 336-777-3036

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse,  New York,  13217
United States
Recruiting Jeffrey  Kirshner 315-472-7504

Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk,  Virginia,  23502
United States
Recruiting Paul  Conkling 757-466-8683

Cooper University Hospital *Recruiting*
Camden,  New Jersey,  08103
United States
Recruiting Edison  Catalano 856-342-2506

MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Lawrence  Feldman 312-335-3614

Louis A. Weiss Memorial Hospital *Recruiting*
Chicago,  Illinois,  60640
United States
Recruiting Keith  Shulman 773-564-5022

Missouri Baptist Cancer Center *Recruiting*
St. Louis,  Missouri,  63131
United States
Recruiting Alan  Lyss 314-996-5514

Veterans Affairs Medical Center - White River Junction *Recruiting*
White River Junction,  Vermont,  05009
United States
Recruiting Joseph  O'Donnell 802-295-9363 ext. 5480

St. Mary's Medical Center *Recruiting*
Huntington,  West Virginia,  25701
United States
Recruiting Gerrit  Kimmey 304-528-4645

Saint Anthony Medical Center *Recruiting*
Rockford,  Illinois,  61108
United States
Recruiting Richard  Nora 815-227-2273

Vermont Cancer Center at University of Vermont *Recruiting*
Burlington,  Vermont,  05401-3498
United States
Recruiting Hyman  Muss 802-847-3827

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Clifford  Hudis 212-639-6483

Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas,  Nevada,  89106
United States
Recruiting Chitha  Hulugalle 702-696-3000

Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75216
United States
Recruiting Barry  Levinson 214-648-4193

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting Karen  Wendling 773-834-7424

North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Daniel  Budman 516-562-8958

University of Minnesota Cancer Center *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Bruce  Peterson 612-624-5631

University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse,  New York,  13210
United States
Recruiting Stephen  Graziano 315-464-8200

Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem,  North Carolina,  27157-1082
United States
Recruiting David  Hurd 336-716-2088

New Hanover Regional Medical Center *Recruiting*
Wilmington,  North Carolina,  28402-9025
United States
Recruiting Cyrus  Kotwall 910-763-4630

Martha Jefferson Hospital *Recruiting*
Charlottesville,  Virginia,  22902
United States
Recruiting Stefan  Gorsch 434-982-8410

Baptist Hospital East - Louisville *Recruiting*
Louisville,  Kentucky,  40207
United States
Recruiting Daniel  Scullin 502-897-1166

Barnes-Jewish Hospital *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Nancy  Bartlett 314-747-3000

Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood,  Florida,  33021
United States
Recruiting Atif  Hussein 954-986-6363

Veterans Affairs Medical Center - Buffalo *Recruiting*
Buffalo,  New York,  14215
United States
Recruiting Lynn  Steinbrenner 716-862-3191

CCOP - Illinois Oncology Research Association *Recruiting*
Peoria,  Illinois,  61602
United States
Recruiting John  Kugler 309-636-3605

New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett,  New Hampshire,  03106
United States
Recruiting Douglas  Weckstein 603-622-6484

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph,  Michigan,  49085
United States
Recruiting Eric  Lester 269-982-4963

FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst,  North Carolina,  28374
United States
Recruiting Ellen  Willard 910-295-9205

CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas,  Nevada,  89106
United States
Recruiting John  Ellerton 702-384-0013

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill,  North Carolina,  27599-7295
United States
Recruiting Thomas  Shea 919-966-7746

New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City,  New York,  10021
United States
Recruiting Scott  Wadler 212-746-2844

Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego,  California,  92161
United States
Recruiting Saeeda  Kirmani 619-552-8585 ext. 3356

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

CCOP - Mount Sinai Medical Center *Recruiting*
Miami,  Florida,  33140
United States
Recruiting Rogerio  Lilenbaum 305-674-2625

Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus,  Ohio,  43210-1240
United States
Recruiting Clara  Bloomfield 614-293-7518

CCOP - Evanston *Recruiting*
Evanston,  Illinois,  60201
United States
Recruiting Gershon  Locker 847-570-2518

Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20007
United States
Recruiting Edward  Gelmann 202-444-7303

Veterans Affairs Medical Center - Syracuse *Recruiting*
Syracuse,  New York,  13210
United States
Recruiting Stephen  Graziano 315-476-7461

Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis,  Minnesota,  55417
United States
Recruiting Vicki  Morrison 612-725-2000 ext. 4135

University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester,  Massachusetts,  01655
United States
Recruiting Pankaj  Bhargava 508-856-6884

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-271-4022

Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore,  Maryland,  21201
United States
Recruiting Martin  Edelman 410-328-2703

Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon,  New Hampshire,  03756-0002
United States
Recruiting Marc  Ernstoff 603-650-5534

Palm Beach Cancer Institute *Recruiting*
West Palm Beach,  Florida,  33401
United States
Recruiting Robert  Jacobson 561-366-4150

CCOP - North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Vincent  Vinciguerra 516-562-8915

Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville,  North Carolina,  28805
United States
Recruiting John  Lucke 828-299-2540

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting George  Canellos 617-632-3470

Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne,  Indiana,  46885-5099
United States
Recruiting Sreenivasa  Nattam 219-484-8830

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75390
United States
Recruiting Debasish  Tripathy 214-648-5113

UCSF Comprehensive Cancer Center *Recruiting*
San Francisco,  California,  94115
United States
Recruiting Alan  Venook 800-888-8664

Northeast Alabama Regional Medical Center *Recruiting*
Anniston,  Alabama,  36207
United States
Recruiting Thomas  Twele 256-236-2549

MBCCOP - Massey Cancer Center *Recruiting*
Richmond,  Virginia,  23298-0037
United States
Recruiting John  Roberts 804-828-0450

CCOP - Christiana Care Health Services *Recruiting*
Newark,  Delaware,  19713
United States
Recruiting Stephen  Grubbs 302-623-4100

NorthEast Oncology Associates *Recruiting*
Concord,  North Carolina,  28025
United States
Recruiting James  Wall 704-783-1370

Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica,  New York,  11432
United States
Recruiting Hans  Grunwald 718-883-4118

Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Thomas  Lad 312-996-2046

Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia,  Missouri,  65203
United States
Recruiting Michael  Perry 573-882-4979

Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City,  Iowa,  52242-1009
United States
Recruiting Gerald  Clamon 319-356-1932

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles,  California,  90048
United States
Recruiting Alan  Lefor 310-423-5874

West Suburban Center for Cancer Care *Recruiting*
River Forest,  Illinois,  60305
United States
Recruiting John  Showel 708-763-2700

Lifespan: The Miriam Hospital *Recruiting*
Providence,  Rhode Island,  02906
United States
Recruiting William  Sikov 401-793-7151

Duke Comprehensive Cancer Center *Recruiting*
Durham,  North Carolina,  27710
United States
Recruiting Jeffrey  Crawford 919-684-5195

Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla,  California,  92093-0658
United States
Recruiting Stephen  Seagren 858-657-7020

Cape Fear Valley Health System *Recruiting*
Fayetteville,  North Carolina,  28302-2000
United States
Recruiting Kamal  Bakri 910-609-6910

Veterans Affairs Medical Center - Durham *Recruiting*
Durham,  North Carolina,  27705
United States
Recruiting Michael  Kelley 919-286-0411

Broward General Medical Center *Recruiting*
Ft. Lauderdale,  Florida,  33316
United States
Recruiting Luis  Barreras 954-771-0692

CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend,  Indiana,  46601
United States
Recruiting Rafat  Ansari 574-284-7977

Mount Sinai Medical Center, NY *Recruiting*
New York City,  New York,  10029
United States
Recruiting Lewis  Silverman 212-241-5520

Veterans Affairs Medical Center - Columbia (Truman Memorial) *Recruiting*
Columbia,  Missouri,  65201
United States
Recruiting William  Patterson 573-882-6163


Additional Information:
Study ID Numbers:
  CDR0000335518;  CALGB-500102
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072163

Other Brain Metastases Studies:
1. Vaccine Therapy in Treating Patients With Metastatic Melanoma

2. Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma

3. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma

4. Interferon alfa-2b With or Without Radiation Therapy in Treating Patients With Melanoma That Has Metastasized to Lymph Nodes in the Neck, Under the Arm, or in the Groin

5. Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery

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Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma

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