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

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

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



- 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

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.

Inclusion Criteria


- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Safety Issue:


Principal Investigator

Myrna Rosenfeld, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Food and Drug Administration

Study ID:

NABTT-0501 CDR0000454915



Start Date:

January 2006

Completion Date:

April 2010

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Lurleen Wallace Comprehensive Cancer at University of Alabama-BirminghamBirmingham, Alabama  35294