Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma

Completed · Phase 2

Conditions studied: Recurrent Melanoma, Stage IV Melanoma, Tumors Metastatic to Brain

In brief

This phase II trial is studying how well giving temozolomide together with thalidomide works in treating patients with brain metastases secondary to melanoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells

Key facts

Study ID

NCT00072163

Run by

National Cancer Institute (NCI)

People needed

50

Starts

2003-10-01

Last updated by the study team

2013-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed metastatic melanoma
• Clinical evidence of brain metastases
• At least 1 unidimensionally measurable brain lesion at least 2.0 cm by conventional techniques OR at least 1.0 cm by spiral CT scan or MRI
• The following lesions are not considered measurable:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Lymphangitis cutis/pulmonis
• Abdominal masses that are not confirmed and followed by imaging techniques
• Cystic lesions
• Lesions situated in a previously irradiated area, unless new growth is documented
• Performance status - CTC 0-1
• Granulocyte count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• AST and ALT no greater than 2.5 times upper limit of normal (ULN)
• Lactic dehydrogenase no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN
• Creatinine no greater than 2 mg/dL
• No history of active angina
• No history of significant ventricular arrhythmia
• No history of deep vein thrombosis
• No myocardial infarction within the past 6 months
• No acute abnormality by EKG
• No uncontrolled arrhythmia

Where it is running

• Cancer and Leukemia Group B — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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