Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Study Overview
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Brief Summary
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RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Detailed Description
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OBJECTIVES: Determine the efficacy of poly ICLC and radiotherapy, in terms of total survival from date of diagnosis, in patients with newly diagnosed glioblastoma multiforme. Determine the safety and toxicity profile of this regimen in these patients. Determine the 12-month survival rate in patients treated with this regimen. Assess progression-free survival at 6 months and median progression-free survival from date of diagnosis of patients treated with this regimen. Assess response in patients treated with this regimen. Assess changes in neurological status in patients treated with this regimen. OUTLINE: This is a multicenter study. Within 1-4 weeks after surgery, patients receive poly ICLC intramuscularly 3 times weekly (on days 1, 3, and 5). Treatment continues in the absence of disease progression or unacceptable toxicity. One week after the initiation of poly ICLC, patients undergo external beam radiotherapy once daily 5 days a week for 6 weeks. Patients are followed monthly for 1 year and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Official Title
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Phase II Trial Of Poly-ICLC For Glioblastoma

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: poly ICLC


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma by biopsy or resection within the past 28 days PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy More than 8 weeks Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 2 times ULN Renal Creatinine less than 1.5 mg/dL Other No significant medical illness that cannot be controlled adequately with appropriate therapy or that would compromise tolerability of study therapy No other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that disease for at least 3 years No active infection No disease that would obscure toxicity or dangerously alter drug metabolism No other serious concurrent medical illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior polifeprosan 20 with carmustine implant (Gliadel wafer) No concurrent chemotherapy Endocrine therapy Concurrent corticosteroids to treat symptoms or prevent complications are allowed Radiotherapy No prior radiotherapy to the brain No concurrent stereotactic radiosurgery No concurrent brachytherapy Surgery See Disease Characteristics Other No prior cytotoxic or noncytotoxic drug therapy for GBM No prior experimental drug therapy for GBM No other concurrent cytotoxic or noncytotoxic drug therapy for GBM Concurrent analgesics, antiepileptics, or other drugs to treat symptoms or prevent complications are allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: poly-ICLC Newly diagnosed GBM<br>Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy Intramuscular injection Drug Poly-ICLC | Drug: poly ICLC<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival in Pts With Newly Diagnosed GBM | Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine 6 Months Progression Free Survival | Patients evaluated from date of diagnosis to the 6 month scan | 6 months | 
| Determine the 12-month Survival Rate | 12-month survival rate calculated from date of diagnosis | 1 year | 
| to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients | CTCAE 4 | 2 years | 
| To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC | Descriptive measure per investigator to describe change in neurological status post-intervention. | 1 year | 
| To Determine Tumor Response | Tumor response to treatment with Poly-ICLC | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma