Phase II Study of R115777 for the Treatment of Adults With Newly Diagnosed Glioblastoma Multiforme

Status: Completed
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2

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.

Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No

• 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

United States
New Approaches to Brain Tumor Therapy Consortium
Time Frame
Start Date: August 2003
Completion Date: January 2007
Target number of participants: 54
Experimental: Treatment (tipifarnib)
INDUCTION THERAPY: Patients receive oral tipifarnib twice daily for 3 weeks. Treatment repeats every 4 weeks for up to 3 courses.~RADIOTHERAPY: Within 14 days after the completion of induction therapy, patients undergo radiotherapy daily, 5 days a week, for 6 weeks.~MAINTENANCE THERAPY: Two weeks after the completion of radiotherapy, patients receive additional tipifarnib as in induction therapy.~Treatment continues in the absence of disease progression or unacceptable toxicity.
Leads: National Cancer Institute (NCI)

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