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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000327811 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-2012-02554 | Registry Identifier | CTRP (Clinical Trials Reporting System) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with stage IV malignant melanoma with measurable and unresectable cancer limited to the central nervous system.
OBJECTIVES:
Primary
Secondary
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 18-41 patients will be accrued for this study within 13-30 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiation + temozolomide | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temozolomide | Drug |
| ||
| radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed response rate | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Up to 5 years | |
| Overall survival | Up to 5 years | |
| Change in performance status |
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DISEASE CHARACTERISTICS:
Histologically confirmed stage IV malignant melanoma with measurable and unresectable disease limited to the central nervous system (CNS)
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
No evidence of metastatic disease outside of the CNS
PATIENT CHARACTERISTICS:
Age
Performance status
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Svetomir Markovic, MD, PhD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | United States | ||
| Mayo Clinic - Jacksonville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20042969 | Result | Schild SE, Behl D, Markovic SN, Brown PD, Sande JR, Deming RL, Rowland KM Jr, Bearden JD. Brain metastases from melanoma: is there a role for concurrent temozolomide in addition to whole brain radiation therapy? Am J Clin Oncol. 2010 Dec;33(6):633-6. doi: 10.1097/COC.0b013e3181c4c54b. |
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|
| Up to 5 years |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| McFarland Clinic, PC | Ames | Iowa | 50010 | United States |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | United States |
| Mercy Capitol Hospital | Des Moines | Iowa | 50307 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316-2301 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Medical Oncology and Hematology Associates - West Des Moines | West Des Moines | Iowa | 50266 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | United States |
| Meeker County Memorial Hospital | Lichfield | Minnesota | 55355 | United States |
| HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | 55109 | United States |
| Minnesota Oncology Hematology, PA at Maplewood Cancer Center | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | United States |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Health Services | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital Cancer Care Center | Saint Paul | Minnesota | 55101 | United States |
| St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Saint Francis Cancer Center | Shakopee | Minnesota | 55379 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | United States |
| Woodwinds Health Campus | Woodbury | Minnesota | 55125 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Middletown Regional Hospital | Middletown | Ohio | 45044 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | United States |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
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