Dasatinib Plus Radiation Therapy/Temozolomide in Newly-Diagnosed Glioblastoma
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|ClinicalTrials.gov Identifier: NCT00895960|
Recruitment Status : Terminated (Sponsor withdrew support; Study did not progress to Phase II.)
First Posted : May 11, 2009
Last Update Posted : November 8, 2018
-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).
- 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.
-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.
- 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.
-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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma CNS Disease Brain Diseases||Drug: Dasatinib Radiation: RT (Radiotherapy) Drug: TMZ (Temozolomide)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of Dasatinib (Sprycel) With Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma|
|Actual Study Start Date :||May 7, 2009|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Experimental: Dasatinib Plus RT + TMZ
Dasatinib (Sprycel) with Radiotherapy (RT) and 6 weeks of concomitant Temozolomide (TMZ)
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).
Other Name: Radiation Therapy
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.
Other Name: Temodar
- Maximum tolerated dose (MTD) [ Time Frame: Baseline then after each 28-day study cycle ]The MTD of dasatinib will be that dose at which fewer than one-third of participants experience dose limiting toxicity (DLT). Escalations are planned in groups of three patients, with an additional three patients to be added at the first indication of DLT.
- Overall survival (OS) [ Time Frame: Baseline till participant death or end of follow-up period, approximately 12 to 18 months (following 12 cycles of treatment) ]Overall survival (OS) is defined as the time from surgical diagnosis to the date of death from any cause. For participants who are still alive at the time of analysis, survival time will be censored at the last contact date.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895960
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||John De Groot, MD||UT MD Anderson Cancer Center|