Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NABTT-2200 JHOC-NABTT-2200, NCT00058097

Objectives

1. Determine the progression-free and overall survival of patients with newly diagnosed glioblastoma multiforme treated with tipifarnib and radiotherapy.
2. Determine the response rate of patients treated with this regimen.
3. Determine the toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed supratentorial grade IV astrocytoma
  • Glioblastoma multiforme



• Measurable and contrast-enhancing tumor on the postoperative MRI/CT scan

Prior/Concurrent Therapy:

Biologic therapy

• No prior immunotherapy for brain tumor
• No prior biologic therapy for brain tumor, including any of the following:
  • Immunotoxins
  • Immunoconjugates
  • Antisense therapy
  • Peptide receptor antagonists
  • Interferons
  • Interleukins
  • Tumor-infiltrating lymphocytes
  • Lymphokine-activated killer cell therapy
  • Gene therapy

Chemotherapy

• No prior chemotherapy for brain tumor
• No prior polifeprosan 20 with carmustine implant (Gliadel wafer)

Endocrine therapy

• No prior hormonal therapy (except glucocorticoids) for brain tumor
• Must be maintained on a stable corticosteroid regimen prior to study entry

Radiotherapy

• No prior radiotherapy for brain tumor

Surgery

• See Disease Characteristics
• Recovered from prior surgery

Other

• At least 10 days since prior hepatic metabolic enzyme-inducing anticonvulsant drugs, including the following:
  • Phenytoin
  • Carbamazepine
  • Phenobarbital
  • Primidone
  • Oxcarbazepine
• No other concurrent investigational agents

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9 g/dL

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• AST/ALT no greater than 4 times upper limit of normal

Renal

• Creatinine no greater than 1.5 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Mini-mental state exam score at least 15
• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
• No serious concurrent infection that would preclude study therapy
• No other medical illness that would preclude study therapy

Expected Enrollment

A minimum of 54 patients will be accrued for this study within 11-14 months.

Outline

This is a multicenter study.

• 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.

Patients are followed every 2 months.

Lustig R, Mikkelsen T, Lesser G, et al.: Phase II preradiation R115777 (tipifarnib) in newly diagnosed GBM with residual enhancing disease. Neuro Oncol 10 (6): 1004-9, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

New Approaches to Brain Tumor Therapy

Robert Lustig, MD, Protocol chair		Ph: 215-349-8429 Email: lustig@xrt.upenn.edu

Registry Information
Official Title		Phase II Study Of R115777 For The Treatment Of Adults With Newly Diagnosed Glioblastoma Multiforme
Trial Start Date		2003-08-28
Trial Completion Date		2009-01-30
Registered in ClinicalTrials.gov		NCT00058097
Date Submitted to PDQ		2003-02-13
Information Last Verified		2004-04-09
NCI Grant/Contract Number		CA062475

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