Status:
COMPLETED
Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 ...
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 g...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00262730
Start Date
January 1 2006
End Date
April 1 2010
Last Update
June 12 2019
Active Locations (9)
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1
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
2
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
3
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
4
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410