Enzastaurin Versus Lomustine in Glioblastoma

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

Official Title
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Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma

Conditions
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Glioblastoma

Intervention / Treatment
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* Drug: enzastaurin
* Drug: lomustine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient presents with histologically confirmed diagnosis of brain cancer (specifically glioblastoma multiforme). Your cancer has returned following therapy. Patient may have undergone prior surgery to remove cancer. Patient must be able to care for self. Exclusion Criteria: 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. 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. Patients receiving medication for seizures must discontinue 14 days prior to enrolling. Cannot be on blood thinning medication at study enrollment. Cannot be on other medicines to prevent cancer at study enrollment. Patients are not allowed to enter the study if they have previously taken Enzastaurin, Lomustine and/or Bevacizumab.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: enzastaurin<br>* 1125 mg loading dose then 500 mg, oral, daily, 6 week cycles until PD<br>* Other names: LY317615;|
| Active Comparator: B<br> | Drug: lomustine<br>* 100-130 mg/m2, oral once, every 6 weeks until PD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | baseline to measured progressive disease (PD) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure survival to see how the tumor responded to the therapy and how long the response lasted using MRI (a scanning technique). |  | 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). |  | over entire study | 
| To measure changes from baseline and a neurologic exam. |  | baseline, each cycle | 
| To review all bad reactions reported by the patient and detected in blood tests. |  | each cycle | 
| To review the effect of the cancer on the patient's ability to care for themselves and on their general health status. |  | over entire study | 
| To determine through blood tests how long the medication is in the patient's body. |  | 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. |  | baseline, cycle 2, end of study |