Clinical trial · Interventional
Sorafenib and Temozolomide in Treating Patients With Stage III or Stage IV Melanoma
Open-label, Single Center, Uncontrolled Phase I/II Study Evaluating the Safety and Maximum Tolerated Dose of Daily Sorafenib Administered in Combination With Prolonged Temozolomide in Patients With Metastatic Melanoma
- 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: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with temozolomide may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving sorafenib together with temozolomide in treating patients with stage III or stage IV melanoma.
Conditions
Conditions (1)
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 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| sorafenib tosylate | Drug | Sorafenib Tosylate | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose (Phase I)
- measure
- Progression-free survival at 12 weeks (Phase II)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of unresectable or metastatic melanoma * Stage III or IV disease * Previously treated or untreated metastatic disease * At least one unidimensionally measurable lesion by RECIST criteria by scan or MRI * No concurrent brain or CNS metastases PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Life expectancy ≥ 3 months * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin \> 9 g/dL * PT, INR, and PTT \< 1.5 times upper limit of normal (ULN) * Transaminases \< 2.5 times ULN (\< 5 in the case of liver metastases) * Amylase and lipase \< 1.5 times ULN * Bilirubin ≤ 1.5 times ULN * Serum creatinine \< 1.5 times ULN * Normal respiratory, cardiac, and neurological function * Not pregnant or nursing * No history of any of the following cardiac conditions: * NYHA class II-IV heart failure * Coronary disease * Myocardial infarction within the past 6 months * Cardiac arrhythmia requiring treatment with something other than beta-blockers or digoxin * Severe uncontrolled hypertension * No severe active infection \> grade 2 * No epilepsy requiring medical treatment * No other cancer except for carcinoma in situ of the cervix, basal cell carcinoma, superficial bladder tumors, or curatively treated cancer \> 3 years ago * No HIV or hepatitis B or C positivity * No lactase or galactokinase deficiency, galactose intolerance, or disease accompanied by malabsorption of glucose or galactose * No allergy to the study drugs or to dacarbazine * Able to swallow medications * No patients deprived of liberty * No psychological, familial, social, or geographic conditions that would preclude clinical follow up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior organ transplantation * No prior temozolomide or sorafenib tosylate * More than 30 days since other prior antitumor chemotherapy, immunotherapy, hormonal therapy, or investigational agent * More than 30 days since prior study drugs * More than 3 weeks since prior radiotherapy * More than 3 weeks since prior biological response modifiers (i.e., filgrastim \[G-CSF\])
References
Publications (0)
Data not yet available