Brief Summary

This phase I trial is studying the side effects and best dose of temsirolimus when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma multiforme. Temsirolimus 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temsirolimus together with temozolomide and radiation therapy may kill more tumor cells.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Geographic Reach

1 country

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2006

Completed

10 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed

Last Updated

April 10, 2013

Status Verified

April 1, 2013

Enrollment Period

4.5 years

First QC Date

April 19, 2006

Last Update Submit

April 9, 2013

Conditions

Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma

Outcome Measures

Primary Outcomes (6)

Maximally tolerated dose (MTD), determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Up to 24 weeks
Time to treatment related toxicity as assessed by hematologic measures and CTCAE v3.0
From registration to documentation of toxicity, up to 5 years
Time to treatment related toxicity greater than grade 3, assessed by CTCAE v3.0
From registration to documentation of toxicity, up to 5 years
Time to progression
From registration to documentation of progression, up to 5 years
Time to treatment failure
Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals.The effect of dose and ancillary dichotomized covariates such as gender or age (\<50 years versus 50+ years) will be explored using logrank testing involving one covariate at a time.
From registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by patient, up to 5 years
Response to therapy associated with patient outcome, as assessed by automated morphological MRI change detector and physiological MRI techniques, including diffusion-weighted imaging, perfusion-weighted imaging, and chemical shift imaging
Logistic regression and Cox proportional hazards models will be used to determine the association between changes in tumor volume (as assessed by a software package) and tumor response and 12-month survival (logistic regression) and progression-free and overall survival (Cox proportional hazards models).
Up to 5 years

Study Arms (1)

Treatment (temsirolimus, temozolomide, radiation therapy)

EXPERIMENTAL

GROUP 1: (temsirolimus with radiation and temozolomide) Patients receive temsirolimus IV over 30 minutes once weekly. Beginning 7-10 days later, patients also receive oral temozolomide daily and undergo concurrent 3-D conformal radiotherapy or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients with stable or responding disease proceed to adjuvant therapy. GROUP 2: (radiation and temozolomide) Patients receive oral temozolomide daily and undergo concurrent 3-D conformal radiotherapy or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients with stable or responding disease proceed to adjuvant therapy. ADJUVANT THERAPY: Beginning 4-6 weeks after the completion of chemoradiotherapy patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Other: pharmacological studyProcedure: adjuvant therapyRadiation: 3-dimensional conformal radiation therapyRadiation: intensity-modulated radiation therapyDrug: temsirolimusDrug: temozolomide