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

Phase 2

Terminated

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Drug: poly ICLC

• Registration Number: NCT00052715
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-10-23
• Study First Submitted: 2003-01-24
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-02-25
• Study Completion: 2009-01-01
• Results First Submitted: 2017-01-26
• Results First Submitted QC: 2017-01-26
• Results First Posted: 2017-03-16
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-22
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
poly-ICLC Newly diagnosed GBM	poly ICLC	Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy Intramuscular injection Drug Poly-ICLC

Primary Outcome Measures

Name	Time	Method
Overall Survival in Pts With Newly Diagnosed GBM	2 years	Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States