Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed Glioblastoma Multiforme - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00262730

Purpose

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	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: poly ICLC Drug: temozolomide Procedure: adjuvant therapy Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Temozolomide Poly iclc

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial of Radiation Plus Temozolomide Followed by Adjuvant Temozolomide and Poly-ICLC in Patients With Newly Diagnosed Glioblastoma Multiforme

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Survival [ Designated as safety issue: No ]

Estimated Enrollment:	96
Study Start Date:	January 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262730

Locations

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Myrna Rosenfeld, MD, PhD

University of Pennsylvania

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000454915, NABTT-0501
Study First Received:	December 6, 2005
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00262730
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Interferons
Poly ICLC
Central Nervous System Neoplasms
Temozolomide
Neuroectodermal Tumors

Glioblastoma multiforme
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Interferon Inducers
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Physiological Effects of Drugs

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009