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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT02065466
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nab-paclitaxel — DRUG
  • Temozolomide — DRUG
  • Bevacizumab — DRUG

Study Details

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).

Key Dates

First listed
Feb 19, 2014
Start date
Jul 31, 2014
Status verified
Apr 2016
Primary completion
Feb 28, 2015
Completion
Aug 31, 2015

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination
    nab-paclitaxel and temozolomide combined with full dose of bevacizumab

Primary Outcome Measure

Maximum Tolerance Dose [ Time Frame: Beginning of Treatment to unstable disease or discontinuation (6 months) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Arizona Cancer Center at University of Arizona Health Sciences CenterTucsonArizona85724-5024-
University of Arizona Cancer CenterTucsonArizona85742-

Find similar trials in Tucson, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Arizona Cancer Center at University of Arizona Health Sciences Center· Tucson, AZUniversity of Arizona Cancer Center· Tucson, AZ

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