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Phase II Study of Temozolomide and Radiotherapy in Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Disease of the Central Nervous System
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer of the Central Nervous System
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Closed | 18 and over | NCCTG-N0274
N0274, NCT00068666 |
Objectives Primary - Determine the response rate in patients with stage IV malignant melanoma with measurable and unresectable disease of 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.
Entry Criteria Disease Characteristics:
- Histologically confirmed stage IV malignant melanoma with measurable and unresectable disease limited to the central nervous system (CNS)
- 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
- No evidence of metastatic disease outside of the CNS
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 Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- 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
Expected Enrollment 41A total of 18-41 patients will be accrued for this study within 13-30 months. Outcomes Primary Outcome(s)Confirmed response rate
Secondary Outcome(s)Progression-free survival
Overall survival
Change in performance status
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.
Trial Contact Information
Trial Lead Organizations North Central Cancer Treatment Group | | | | Svetomir Markovic, MD, PhD, Protocol chair | | | | | Paul Brown, MD, Protocol co-chair | | | | | Julie Hammack, MD, Protocol co-chair | | | | | James Ingle, MD, Protocol co-chair | | | | | Edward Creagan, MD, Protocol co-chair | | | | | Judith Kaur, MD, Protocol co-chair | | | | | Evanthia Galanis, MD, Protocol co-chair | | | | | Charles Loprinzi, MD, Protocol co-chair | | | | | Henry Pitot, MD, Protocol co-chair | | | | | Michael Gornet, MD, Protocol co-chair | | | | | Ravi Rao, MD, MBBS, Protocol co-chair | | | | | Richard Deming, MD, Protocol co-chair | | | |
| Registry Information | | | Official Title | | A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System | | | Trial Start Date | | 2004-01-09 | | | Registered in ClinicalTrials.gov | | NCT00068666 | | | Date Submitted to PDQ | | 2003-08-04 | | | Information Last Verified | | 2007-01-12 | | | NCI Grant/Contract Number | | CA25224 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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