Metastatic Melanoma Clinical Trial
Official title:
A Pilot Study of the Combination of Nab-paclitaxel, Temozolomide and Bevacizumab in Patients With Metastatic Melanoma With Brain Metastases
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).
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
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