Sorafenib and Temozolomide in Treating Patients With Stage III or Stage IV Melanoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Dacarbazine; Sorafenib; Temozolomide

Criteria

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])