A Phase II Trial of Radiation Plus Temozolomide Followed by Adjuvant Temozolomide and Poly-ICLC in Patients With Newly Diagnosed Glioblastoma Multiforme
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
A Phase II Trial of Radiation Plus Temozolomide Followed by Adjuvant Temozolomide and Poly-ICLC in Patients With Newly Diagnosed Glioblastoma Multiforme
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Survival
Safety Issue:
No
Principal Investigator
Myrna Rosenfeld, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
United States: Food and Drug Administration
Study ID:
NABTT-0501 CDR0000454915
NCT ID:
NCT00262730
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
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
| Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham | Birmingham, Alabama 35294 |
