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

NCT02065466 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2016-04-21

No results posted yet for this study

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

Interventions

DRUG

nab-paclitaxel

DRUG

Temozolomide

DRUG

Bevacizumab

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Lee Cranmer, MD · University of Arizona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-02-28
Completion
2015-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02065466 on ClinicalTrials.gov