Enzastaurin Versus Lomustine in Glioblastoma

Eli Lilly and Company397 enrolled

Overview

This protocol will test the activity of Enzastaurin vs. Lomustine in the treatment of recurrent brain cancer (specifically intracranial glioblastoma multiforme).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

397

Conditions

Glioblastoma

Interventions

enzastaurinDRUG

1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD

lomustineDRUG

100-130 mg/m2, oral once, every 6 weeks until PD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient presents with histologically confirmed diagnosis of brain cancer (specifically glioblastoma multiforme). 2. Your cancer has returned following therapy. 3. Patient may have undergone prior surgery to remove cancer. 4. Patient must be able to care for self. Exclusion Criteria: 1. Have a second type of cancer (except adequately treated basal cell carcinoma of the skin). Patient who has had another cancer in the past, must be free of cancer for more than 2 years. 2. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of entry. 3. Patients receiving medication for seizures must discontinue 14 days prior to enrolling. 4. Cannot be on blood thinning medication at study enrollment. 5. Cannot be on other medicines to prevent cancer at study enrollment. 6. Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab.

Locations (98)

Outcomes

Primary Outcomes

The primary objective is to compare Enzastaurin versus Lomustine in patients who for the second time have brain cancer (specifically intracranial glioblastoma) to see what effect the drugs have on keeping the disease from progressing (worsening).

Time frame: baseline to measured progressive disease (PD)

Secondary Outcomes

To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique).

Time frame: time of response to progressive disease

To measure changes in patient's ability to care for themselves (this will be determined through a standard survey).

Time frame: over entire study

To measure changes from baseline and a neurologic exam.

Time frame: baseline, each cycle

To review all bad reactions reported by the patient and detected in blood tests.

Time frame: each cycle

To review the effect of the cancer on the patient's ability to care for themselves and on their general health status.

Time frame: over entire study

To determine through blood tests how long the medication is in the patient's body.

Time frame: cycle 1, cycle 4

To review through testing of tumor and blood samples to see if there are reasons why some patients responded to the drugs better than other patients.

Time frame: baseline, cycle 2, end of study

Data from ClinicalTrials.gov

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