Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed · Phase 2

Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

In brief

Phase II trial to study the effectiveness of combining tipifarnib with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining tipifarnib with radiation therapy may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.

Key facts

Study ID

NCT00058097

Run by

National Cancer Institute (NCI)

People needed

54

Starts

2003-08-01

Last updated by the study team

2013-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
• Patients must not have received prior radiation therapy, chemotherapy, hormonal therapy, immunotherapy or therapy with biologic agents (including immunotoxins immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy) or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
• Patients must have measurable and contrast-enhancing tumor on the post operative, pretreatment MRI/CT scan (within two weeks of starting treatment)
• Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of treatment
• Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
• Absolute neutrophil count >= 1500/mm\^3
• Platelets >= 100,000/mm\^3
• Hemoglobin >= 9 g/dl
• Creatinine =< 1.5 mg/dl
• Total bilirubin =< 2.0 mg/dl
• Transaminases =< 4 times above the upper limits of the institutional norm
• Patients must be able to provide written informed consent and must be aware of the investigational nature of this study
• Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; the anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant; female patients of child-bearing potential must have a negative pregnancy test
• Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast; patients with prior malignancies must be disease-free for >= five years
• Patients must have a mini-mental state exam score (MMSE) of >= 15

You may not qualify if…

• Patients with serious concurrent infection or medical illness which would jeopardize the ability of the patient to receive the chemotherapy outlined in this protocol with reasonable safety
• Patients who are pregnant or breast-feeding
• Patients who have received prior radiation therapy, chemotherapy, hormonal therapy (except glucocorticoids), immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy) for their brain tumor
• Patients receiving concurrent investigational agents
• Patients who have received Gliadel wafer therapy may not participate in this study

Where it is running

• New Approaches to Brain Tumor Therapy Consortium — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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