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Clinical Trials/NCT00052715
NCT00052715TerminatedPhase 2

Phase II Trial Of Poly-ICLC For Glioblastoma

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 country31 target enrollmentStarted: October 23, 2002Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
31
Locations
1
Primary Endpoint
Overall Survival in Pts With Newly Diagnosed GBM

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

poly-ICLC Newly diagnosed GBM

Experimental

Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy

Intramuscular injection

Drug Poly-ICLC

Intervention: poly ICLC (Drug)

Outcomes

Primary Outcomes

Overall Survival in Pts With Newly Diagnosed GBM

Time Frame: 2 years

Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM

Secondary Outcomes

  • To Determine 6 Months Progression Free Survival(6 months)
  • Determine the 12-month Survival Rate(1 year)
  • to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients(2 years)
  • To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC(1 year)
  • To Determine Tumor Response(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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