Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM

Phase 2

Completed

Interventions: Drug: poly ICLC
Drug: temozolomide
Radiation: radiation therapy

Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Biological therapies, such as poly ICLC, may stimulate the immune system in different ways and stop tumor cells from growing. Giving poly ICLC after radiation therapy and temozolomide may stop any remaining tumor cells from growing.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with temozolomide followed by temozolomide and poly ICLC works in treating patients with newly diagnosed glioblastoma multiforme.

Detailed Description: OBJECTIVES:

Primary

* Evaluate the safety and efficacy of radiation plus low-dose temozolomide followed by adjuvant temozolomide and intramuscular poly ICLC for adult patients with newly diagnosed glioblastoma multiforme.

Secondary

* Estimate the frequency of toxicity associated with this treatment regimen.

OUTLINE: This is an open-label, multicenter study.

* Induction chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6 weeks. During the same 6 weeks, patients also receive oral temozolomide once daily. Four weeks later, patients are evaluated for disease progression. Patients with progressive disease are removed from the study. Patients with no progressive disease proceed to maintenance therapy.

* Maintenance therapy: Patients receive oral temozolomide once daily on days 1-5 (week 1). Patients also receive poly ICLC intramuscularly three times a week in weeks 2-8. Courses repeat every 9 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2 months for survival.

PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Treatment Arm	radiation therapy	RT + TMZ 6wks, followed by poly ICLC, temozolomide, radiation: radiation therapy
Treatment Arm	temozolomide	RT + TMZ 6wks, followed by poly ICLC, temozolomide, radiation: radiation therapy
Treatment Arm	poly ICLC	RT + TMZ 6wks, followed by poly ICLC, temozolomide, radiation: radiation therapy

Primary Outcome Measures

Name	Time	Method
Survival	30 months	survival time is defined from time of histological diagnosis to death occurrence.

Secondary Outcome Measures

Name	Time	Method

Locations (9): Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
🇺🇸
Birmingham, Alabama, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸
Winston-Salem, North Carolina, United States
Winship Cancer Institute of Emory University
🇺🇸
Atlanta, Georgia, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸
Cleveland, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
🇺🇸
Boston, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸
Tampa, Florida, United States