Clinical trial · Interventional
Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain
Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy 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. It is not yet known if chemotherapy is more effective with or without radiation therapy in treating brain metastases. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy to the brain in treating patients who have stage IV melanoma with asymptomatic brain metastases.
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 |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed unresectable metastatic melanoma * Must have asymptomatic brain metastasis that is not amenable to surgery or stereotactic radiosurgery (gamma knife, Linac) * Must have concurrent visceral/soft tissue metastases * At least 1 site of measurable disease (not necessarily the brain metastasis) * Documented evidence of disease progression defined by 1 of the following conditions: * More than 25% increase in the size of at least 1 measurable lesion * Appearance of a new lesion * A significant increase in the size of nonmeasurable disease * No neurological symptoms, including signs of elevated intracranial pressure PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 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 10 g/dL Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT or SGPT less than 3 times ULN * Alkaline phosphatase less than 3 times ULN Renal: * Urea less than 1.5 times ULN * Creatinine less than 1.5 times ULN Other: * No frequent vomiting or medical condition (e.g., partial bowel obstruction) that would interfere with oral medication intake * No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * No uncontrolled infection * HIV negative * No AIDS-related illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No psychological, familial, sociological, or geographical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior cytokine via isolated limb perfusion for local-regional melanoma allowed * No other prior cytokine for metastatic melanoma * No concurrent colony-stimulating factors, including epoetin alfa or filgrastim (G-CSF) * No other concurrent immunologic or biologic therapy Chemotherapy: * Prior chemotherapy via isolated limb perfusion for local-regional melanoma allowed * No other prior chemotherapy for metastatic melanoma * No other concurrent chemotherapy Endocrine therapy: * Concurrent corticosteroids allowed during radiotherapy (arm II only) * No concurrent hormonal therapy Radiotherapy: * See Disease Characteristics * No other concurrent radiotherapy Surgery: * See Disease Characteristics * Recovered from the effects of any prior major surgery Other: * No other concurrent investigational drugs
References
Publications (0)
Data not yet available