1.1. Primary Objectives 1\. To determine if nab-paclitaxel and temozolomide can be combined with full dose of bevacizumab for the therapy of patients with newly diagnosed brain metastases of metastatic malignant melanoma. * To define the MTD of the combination (Phase I component). * To determine progression free survival (Phase II component). 1.2. Secondary Objectives 1. To separately evaluate the response rate and duration of both the brain and extra-cranial systemic metastases. 2. To define the toxicity of the regimen. 3. To tabulate the toxicity of the radiotherapy to the brain and compare with known toxicities of radiotherapy to the brain in melanoma and brain metastases. 4. To use the data generated to plan definitive controlled clinical trials of the combination. 5. To determine the overall response rate (Phase II component).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Maximum Tolerance Dose
To define the MTD of the combination (Phase I component).
Time frame: Beginning of Treatment to unstable disease or discontinuation (6 months)
Progression Free Survival
To determine progression free survival (Phase II component).
Time frame: Treatment to End of Follow-up (6 Months)
Response Rate
To determine the overall response rate (Phase II component).
Time frame: Baseline to end of follow-up (six months)
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