NCT02065466

Combo of Abraxane, TMZ, Bevacizumab in Metastatic Melanoma With Brain Metastases

A Pilot Study of the Combination of Nab-paclitaxel, Temozolomide and Bevacizumab in Patients With Metastatic Melanoma With Brain Metastases

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Metastatic Melanoma
• Brain Metastases

Interventions

Type	Name	Description
DRUG	nab-paclitaxel
DRUG	Temozolomide
DRUG	Bevacizumab

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-02-01
• Completion: 2015-08-01
• First posted: 2014-02-19
• Last updated: 2016-04-21

Locations

2 sites across 1 country: United States