Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-01-01 @ 9:39 AM
Study NCT ID:
NCT02065466
Status:
WITHDRAWN
Last Update Posted:
2016-04-21
First Post:
2014-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combo of Abraxane, TMZ, Bevacizumab in Metastatic Melanoma With Brain Metastases
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
A Pilot Study of the Combination of Nab-paclitaxel, Temozolomide and Bevacizumab in Patients With Metastatic Melanoma With Brain Metastases
Status:
WITHDRAWN
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: