Clinical trial · Interventional
Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer of the Central Nervous System
A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System
NCT00068666CI-TRIAL-00025165terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- radiation + temozolomide
- description
- 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.
- interventionNames
- Drug: temozolomide
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Confirmed response rate
- timeFrame
- Up to 5 years
Secondary outcomes (3)
- measure
- Progression-free survival
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% 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
References
Publications (1)
- RESULTSchild 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. PMID 20042969