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

May 30, 2019 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

A Phase II Trial of Radiation Plus Temozolomide Followed by Adjuvant Temozolomide and Poly-ICLC in Patients With Newly Diagnosed Glioblastoma Multiforme

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
    • Florida
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 118 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme) by biopsy or resection within the past 3 months

PATIENT CHARACTERISTICS:

  • Karnofsky performance status ≥ 60%
  • Absolute neutrophil count ≥ 1500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 mg/dL
  • Transaminases ≤ 4 times above the upper limits of the institutional normal
  • Creatinine ≤ 1.7 mg/dL
  • Not pregnant or breast-feeding
  • Patients must agree to follow acceptable birth control methods to avoid conception
  • Negative pregnancy test
  • Patients must have a Mini Mental State Exam score of ≥ 15
  • No serious concurrent infection or medical illness which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety

  • Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin

    • Patients who have been free of disease (any prior malignancy) for ≥ five years are eligible for this study
  • Patients requiring ongoing therapy for psychoses with antipsychotic medications at the time of enrollment will be ineligible

PRIOR CONCURRENT THERAPY:

  • Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor

    • Prior glucocorticoid therapy is allowed
  • Patients must be willing to forego other cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with poly ICLC plus temozolomide on this protocol
  • No other concurrent therapy for their tumor (i.e., chemotherapeutics or investigational agents)
  • Patients who have received prior Gliadel wafers are not eligible for this study
  • No concurrent prophylactic filgrastim (G-CSF)
  • No concurrent electron, particle, implant, or stereotactic radiosurgery boost

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm

RT + TMZ 6wks, followed by

poly ICLC, temozolomide, radiation: radiation therapy
Drug: poly ICLC
20 mcg/kg 3x each week (Maintenance cycles)
Other Names:
  • Holtonol
Drug: temozolomide
daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)
Other Names:
  • Temodar
Radiation: radiation therapy
RT: 60 Gy (6 weeks) concomitant therapy
Other Names:
  • RT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 30 months
survival time is defined from time of histological diagnosis to death occurrence.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Myrna Rosenfeld, MD, PhD, Abramson Cancer Center of the University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 6, 2005

First Submitted That Met QC Criteria

December 6, 2005

First Posted (Estimate)

December 7, 2005

Study Record Updates

Last Update Posted (Actual)

June 12, 2019

Last Update Submitted That Met QC Criteria

May 30, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NABTT-0501
  • U01CA062475 (U.S. NIH Grant/Contract)
  • NABTT-0501 CDR0000454915
  • NA_00001963 (Other Identifier: JHM IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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