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Dasatinib Plus Radiation Therapy/Temozolomide in Newly-Diagnosed Glioblastoma

NCT00895960 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-11-08

No results posted yet for this study

Summary

Phase I:

Primary Objectives:

-To define the maximum tolerated dose (MTD) of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of concomitant temozolomide (TMZ) administered at 75 mg/m\^2/day in patients with newly-diagnosed glioblastoma (GBM).

Secondary Objectives:

* To characterize the safety profile of dasatinib (Sprycel) in combination with radiotherapy (RT) and concomitant TMZ in patients with newly-diagnosed GBM.
* To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant TMZ in patients with glioblastoma after RT.

STUDY DID NOT PROGRESS TO PHASE II PORTION.

Phase II:

Primary Objectives:

-To determine the effectiveness of dasatinib (Sprycel) with radiotherapy (RT) and 6 weeks of concomitant temozolomide (TMZ) administered at 75 mg/m\^2/day followed by adjuvant temozolomide with concurrent dasatinib in patients with newly-diagnosed glioblastoma (GBM) as measured by overall survival.

Secondary Objectives:

* To determine the efficacy of this treatment as measured by radiographic response (RR), progression-free survival (PFS) and time to progression (TTP).
* To characterize the safety profile of dasatinib (Sprycel) in combination with RT and concomitant TMZ in patients with newly-diagnosed GBM.
* To characterize the safety profile of dasatinib (Sprycel) in combination with adjuvant TMZ in patients with GBM after RT.

Exploratory Objectives:

-To correlate tumor genotype, tumor expression of dasatinib target proteins (e.g. Src, EphA2, c-kit and PDGFR), and PTEN levels with response to therapy with dasatinib and temozolomide.

Conditions

Interventions

DRUG

Dasatinib

Starting dose of 150 mg/day administered by mouth daily on Days 1 to 28 of every 28 day cycle, beginning on the first day of RT.

RADIATION

RT (Radiotherapy)

As a part of standard of care, receive 60 Gy radiation therapy Monday-Friday for a total of 30 radiation treatments (about 6 weeks).

DRUG

TMZ (Temozolomide)

75 mg/m\^2 capsules daily by mouth for up to a maximum of 7 weeks beginning first day of RT until RT end followed by 4 weeks off then 150 mg/m\^2 daily on Days 1-5 of each 28 day study cycle and 200 mg/m\^2 daily of subsequent cycles.

Sponsors & Collaborators

Principal Investigators

  • John De Groot, MD · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-07
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00895960 on ClinicalTrials.gov