Olaparib and Temozolomide in Treating Patients With Relapsed Glioblastoma

Sponsor
Cancer Research UK
Study ID
NCT01390571
Phase
PHASE1
Status
Completed

Conditions

  • Brain and Central Nervous System Tumors

Eligibility Criteria

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

Interventions

  • olaparib — DRUG
  • temozolomide — DRUG
  • gene expression analysis — GENETIC
  • protein expression analysis — GENETIC
  • laboratory biomarker analysis — OTHER
  • pharmacological study — OTHER
  • diffusion-weighted magnetic resonance imaging — PROCEDURE
  • dynamic contrast-enhanced magnetic resonance imaging — PROCEDURE
  • therapeutic conventional surgery — PROCEDURE

Study Details

RATIONALE: Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Olaparib may help temozolomide kill more tumor cells by making tumor cells more sensitive to the drug. PURPOSE: This phase I trial is studying the side effects and best dose of olaparib and temozolomide in treating patients with relapsed glioblastoma.

Key Dates

Start date
Jul 31, 2011
Status verified
Feb 2018
Primary completion
Jun 20, 2017
Completion
Jun 20, 2017

Study Design

Enrollment
34 participants (estimated)
Primary purpose
TREATMENT

Primary Outcome Measure

Detection of olaparib in tumor tissue using liquid chromatography mass spectrometry (LC-MS) seen in at least 1 out of the 6 patients treated in stage 1 of the study

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