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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00262730
Recruitment Status : Completed
First Posted : December 7, 2005
Results First Posted : July 16, 2014
Last Update Posted : June 12, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: poly ICLC Drug: temozolomide Radiation: radiation therapy Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Radiation Plus Temozolomide Followed by Adjuvant Temozolomide and Poly-ICLC in Patients With Newly Diagnosed Glioblastoma Multiforme
Study Start Date : January 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

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 Name: Holtonol

Drug: temozolomide
daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)
Other Name: Temodar

Radiation: radiation therapy
RT: 60 Gy (6 weeks) concomitant therapy
Other Name: RT

Primary Outcome Measures :
  1. Survival [ Time Frame: 30 months ]
    survival time is defined from time of histological diagnosis to death occurrence.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00262730

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United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
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Study Chair: Myrna Rosenfeld, MD, PhD Abramson Cancer Center of the University of Pennsylvania
Publications of Results:
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00262730    
Other Study ID Numbers: NABTT-0501
U01CA062475 ( U.S. NIH Grant/Contract )
NABTT-0501 CDR0000454915
NA_00001963 ( Other Identifier: JHM IRB )
First Posted: December 7, 2005    Key Record Dates
Results First Posted: July 16, 2014
Last Update Posted: June 12, 2019
Last Verified: May 2019
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs